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Sample records for high-quality clinically relevant

  1. Clinically relevant incidental cardiovascular findings in CT examinations

    International Nuclear Information System (INIS)

    Voigt, P.; Fahnert, J.; Kahn, T.; Surov, A.; Schramm, D.; Bach, A.G.

    2017-01-01

    Incidental cardiovascular findings are a frequent phenomenon in computed tomography (CT) examinations. As the result of a dedicated PubMed search this article gives a systemic overview of the current literature on the most important incidental cardiovascular findings, their prevalence and clinical relevance. The majority of incidental cardiovascular findings are of only low clinical relevance; however, highly relevant incidental findings, such as aortic aneurysms, thromboses and thromboembolic events can also occasionally be found, especially in oncology patients. The scans from every CT examination should also be investigated for incidental findings as they can be of decisive importance for the further clinical management of patients, depending on their clinical relevance. (orig.) [de

  2. Can the theoretical domains framework account for the implementation of clinical quality interventions?

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    Lipworth, Wendy; Taylor, Natalie; Braithwaite, Jeffrey

    2013-12-21

    The health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions. We conducted a thematic synthesis of the qualitative literature exploring clinicians' perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF. Our results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions. The TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any

  3. Clinical relevance of studies on the accuracy of visual inspection for detecting caries lesions

    DEFF Research Database (Denmark)

    Gimenez, Thais; Piovesan, Chaiana; Braga, Mariana M

    2015-01-01

    Although visual inspection is the most commonly used method for caries detection, and consequently the most investigated, studies have not been concerned about the clinical relevance of this procedure. Therefore, we conducted a systematic review in order to perform a critical evaluation considering...... the clinical relevance and methodological quality of studies on the accuracy of visual inspection for assessing caries lesions. Two independent reviewers searched several databases through July 2013 to identify papers/articles published in English. Other sources were checked to identify unpublished literature...... to clinical relevance and the methodological quality of the studies were evaluated. 96 of the 5,578 articles initially identified met the inclusion criteria. In general, most studies failed in considering some clinically relevant aspects: only 1 included study validated activity status of lesions, no study...

  4. The Importance of Integrating Clinical Relevance and Statistical Significance in the Assessment of Quality of Care--Illustrated Using the Swedish Stroke Register.

    Directory of Open Access Journals (Sweden)

    Anita Lindmark

    Full Text Available When profiling hospital performance, quality inicators are commonly evaluated through hospital-specific adjusted means with confidence intervals. When identifying deviations from a norm, large hospitals can have statistically significant results even for clinically irrelevant deviations while important deviations in small hospitals can remain undiscovered. We have used data from the Swedish Stroke Register (Riksstroke to illustrate the properties of a benchmarking method that integrates considerations of both clinical relevance and level of statistical significance.The performance measure used was case-mix adjusted risk of death or dependency in activities of daily living within 3 months after stroke. A hospital was labeled as having outlying performance if its case-mix adjusted risk exceeded a benchmark value with a specified statistical confidence level. The benchmark was expressed relative to the population risk and should reflect the clinically relevant deviation that is to be detected. A simulation study based on Riksstroke patient data from 2008-2009 was performed to investigate the effect of the choice of the statistical confidence level and benchmark value on the diagnostic properties of the method.Simulations were based on 18,309 patients in 76 hospitals. The widely used setting, comparing 95% confidence intervals to the national average, resulted in low sensitivity (0.252 and high specificity (0.991. There were large variations in sensitivity and specificity for different requirements of statistical confidence. Lowering statistical confidence improved sensitivity with a relatively smaller loss of specificity. Variations due to different benchmark values were smaller, especially for sensitivity. This allows the choice of a clinically relevant benchmark to be driven by clinical factors without major concerns about sufficiently reliable evidence.The study emphasizes the importance of combining clinical relevance and level of statistical

  5. The Importance of Integrating Clinical Relevance and Statistical Significance in the Assessment of Quality of Care--Illustrated Using the Swedish Stroke Register.

    Science.gov (United States)

    Lindmark, Anita; van Rompaye, Bart; Goetghebeur, Els; Glader, Eva-Lotta; Eriksson, Marie

    2016-01-01

    When profiling hospital performance, quality inicators are commonly evaluated through hospital-specific adjusted means with confidence intervals. When identifying deviations from a norm, large hospitals can have statistically significant results even for clinically irrelevant deviations while important deviations in small hospitals can remain undiscovered. We have used data from the Swedish Stroke Register (Riksstroke) to illustrate the properties of a benchmarking method that integrates considerations of both clinical relevance and level of statistical significance. The performance measure used was case-mix adjusted risk of death or dependency in activities of daily living within 3 months after stroke. A hospital was labeled as having outlying performance if its case-mix adjusted risk exceeded a benchmark value with a specified statistical confidence level. The benchmark was expressed relative to the population risk and should reflect the clinically relevant deviation that is to be detected. A simulation study based on Riksstroke patient data from 2008-2009 was performed to investigate the effect of the choice of the statistical confidence level and benchmark value on the diagnostic properties of the method. Simulations were based on 18,309 patients in 76 hospitals. The widely used setting, comparing 95% confidence intervals to the national average, resulted in low sensitivity (0.252) and high specificity (0.991). There were large variations in sensitivity and specificity for different requirements of statistical confidence. Lowering statistical confidence improved sensitivity with a relatively smaller loss of specificity. Variations due to different benchmark values were smaller, especially for sensitivity. This allows the choice of a clinically relevant benchmark to be driven by clinical factors without major concerns about sufficiently reliable evidence. The study emphasizes the importance of combining clinical relevance and level of statistical confidence when

  6. Clinical quality standards for radiotherapy

    Science.gov (United States)

    2012-01-01

    Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854

  7. Detecting clinically relevant new information in clinical notes across specialties and settings.

    Science.gov (United States)

    Zhang, Rui; Pakhomov, Serguei V S; Arsoniadis, Elliot G; Lee, Janet T; Wang, Yan; Melton, Genevieve B

    2017-07-05

    Automated methods for identifying clinically relevant new versus redundant information in electronic health record (EHR) clinical notes is useful for clinicians and researchers involved in patient care and clinical research, respectively. We evaluated methods to automatically identify clinically relevant new information in clinical notes, and compared the quantity of redundant information across specialties and clinical settings. Statistical language models augmented with semantic similarity measures were evaluated as a means to detect and quantify clinically relevant new and redundant information over longitudinal clinical notes for a given patient. A corpus of 591 progress notes over 40 inpatient admissions was annotated for new information longitudinally by physicians to generate a reference standard. Note redundancy between various specialties was evaluated on 71,021 outpatient notes and 64,695 inpatient notes from 500 solid organ transplant patients (April 2015 through August 2015). Our best method achieved at best performance of 0.87 recall, 0.62 precision, and 0.72 F-measure. Addition of semantic similarity metrics compared to baseline improved recall but otherwise resulted in similar performance. While outpatient and inpatient notes had relatively similar levels of high redundancy (61% and 68%, respectively), redundancy differed by author specialty with mean redundancy of 75%, 66%, 57%, and 55% observed in pediatric, internal medicine, psychiatry and surgical notes, respectively. Automated techniques with statistical language models for detecting redundant versus clinically relevant new information in clinical notes do not improve with the addition of semantic similarity measures. While levels of redundancy seem relatively similar in the inpatient and ambulatory settings in the Fairview Health Services, clinical note redundancy appears to vary significantly with different medical specialties.

  8. Clinical relevance of pharmacist intervention in an emergency department.

    Science.gov (United States)

    Pérez-Moreno, Maria Antonia; Rodríguez-Camacho, Juan Manuel; Calderón-Hernanz, Beatriz; Comas-Díaz, Bernardino; Tarradas-Torras, Jordi

    2017-08-01

    To evaluate the clinical relevance of pharmacist intervention on patient care in emergencies, to determine the severity of detected errors. Second, to analyse the most frequent types of interventions and type of drugs involved and to evaluate the clinical pharmacist's activity. A 6-month observational prospective study of pharmacist intervention in the Emergency Department (ED) at a 400-bed hospital in Spain was performed to record interventions carried out by the clinical pharmacists. We determined whether the intervention occurred in the process of medication reconciliation or another activity, and whether the drug involved belonged to the High-Alert Medications Institute for Safe Medication Practices (ISMP) list. To evaluate the severity of the errors detected and clinical relevance of the pharmacist intervention, a modified assessment scale of Overhage and Lukes was used. Relationship between clinical relevance of pharmacist intervention and the severity of medication errors was assessed using ORs and Spearman's correlation coefficient. During the observation period, pharmacists reviewed the pharmacotherapy history and medication orders of 2984 patients. A total of 991 interventions were recorded in 557 patients; 67.2% of the errors were detected during medication reconciliation. Medication errors were considered severe in 57.2% of cases and 64.9% of pharmacist intervention were considered relevant. About 10.9% of the drugs involved are in the High-Alert Medications ISMP list. The severity of the medication error and the clinical significance of the pharmacist intervention were correlated (Spearman's ρ=0.728/pclinical pharmacists identified and intervened on a high number of severe medication errors. This suggests that emergency services will benefit from pharmacist-provided drug therapy services. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  9. Evaluation of a clinically intuitive quality assurance method

    International Nuclear Information System (INIS)

    Norris, H; Thomas, A; Oldham, M

    2013-01-01

    There is a pressing need for clinically intuitive quality assurance methods that report metrics of relevance to the likely impact on tumor control of normal tissue injury. This paper presents a preliminary investigation into the accuracy of a novel ''transform method'' which enables a clinically relevant analysis through dose-volume-histograms (DVHs) and dose overlays on the patient's CT data. The transform method was tested by inducing a series of known mechanical and delivery errors onto simulated 3D dosimetry measurements of six different head-and-neck IMRT treatment plans. Accuracy was then examined through the comparison of the transformed patient dose distributions and the known actual patient dose distributions through dose-volume histograms and normalized dose difference analysis. Through these metrics, the transform method was found to be highly accurate in predicting measured patient dose distributions for these types of errors.

  10. Clinical relevance in anesthesia journals

    DEFF Research Database (Denmark)

    Lauritsen, Jakob; Møller, Ann M

    2006-01-01

    The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles.......The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles....

  11. Quality Measurement Recommendations Relevant to Clinical Guidelines in Germany and the United Kingdom: (What) Can We Learn From Each Other?

    Science.gov (United States)

    Petzold, Thomas; Deckert, Stefanie; Williamson, Paula R.; Schmitt, Jochen

    2018-01-01

    We conducted a systematic review of clinical guidelines (CGs) to examine the methodological approaches of quality indicator derivation in CGs, the frequency of quality indicators to check CG recommendations in routine care, and clinimetric properties of quality indicators. We analyzed the publicly available CG databases of the Association of the Scientific Medical Societies in Germany (AWMF) and National Institute for Health and Care Excellence (NICE). Data on the methodology of subsequent quality indicator derivation, the content and definition of recommended quality indicators, and clinimetric properties of measurement instruments were extracted. In Germany, no explicit methodological guidance exists, but 3 different approaches are used. For NICE, a general approach is used for the derivation of quality indicators out of quality standards. Quality indicators were defined in 34 out of 87 CGs (39%) in Germany and for 58 out of 133 (43%) NICE CGs. Statements regarding measurement properties of instruments for quality indicator assessment were missing in German and NICE documents. Thirteen pairs of CGs (32%) have associated quality indicators. Thirty-four quality indicators refer to the same aspect of the quality of care, which corresponds to 27% of the German and 7% of NICE quality indicators. The development of a standardized and internationally accepted methodology for the derivation of quality indicators relevant to CGs is needed to measure and compare quality of care in health care systems. PMID:29591538

  12. Clinical Relevance of Adipokines

    Directory of Open Access Journals (Sweden)

    Matthias Blüher

    2012-10-01

    Full Text Available The incidence of obesity has increased dramatically during recent decades. Obesity increases the risk for metabolic and cardiovascular diseases and may therefore contribute to premature death. With increasing fat mass, secretion of adipose tissue derived bioactive molecules (adipokines changes towards a pro-inflammatory, diabetogenic and atherogenic pattern. Adipokines are involved in the regulation of appetite and satiety, energy expenditure, activity, endothelial function, hemostasis, blood pressure, insulin sensitivity, energy metabolism in insulin sensitive tissues, adipogenesis, fat distribution and insulin secretion in pancreatic β-cells. Therefore, adipokines are clinically relevant as biomarkers for fat distribution, adipose tissue function, liver fat content, insulin sensitivity, chronic inflammation and have the potential for future pharmacological treatment strategies for obesity and its related diseases. This review focuses on the clinical relevance of selected adipokines as markers or predictors of obesity related diseases and as potential therapeutic tools or targets in metabolic and cardiovascular diseases.

  13. Technical Note: Display window setting: An important factor for detecting subtle but clinically relevant artifacts in daily CT quality control.

    Science.gov (United States)

    Long, Zaiyang; Bruesewitz, Michael R; Sheedy, Emily N; Powell, Michele A; Kramer, Jacqualynn C; Supalla, Randall R; Colvin, Chance M; Bechel, Jessica R; Favazza, Christopher P; Kofler, James M; Leng, Shuai; McCollough, Cynthia H; Yu, Lifeng

    2016-12-01

    This study aimed to investigate the influence of display window setting on technologist performance detecting subtle but clinically relevant artifacts in daily computed tomography (CT) quality control (dQC) images. Fifty three sets of dQC images were retrospectively selected, including 30 sets without artifacts, and 23 with subtle but clinically relevant artifacts. They were randomized and shown to six CT technologists (two new and four experienced). Each technologist reviewed all images in each of two sessions, one with a display window width (WW) of 100 HU, which is currently recommended by the American College of Radiology, and the other with a narrow WW of 40 HU, both at a window level of 0 HU. For each case, technologists rated the presence of image artifacts based on a five point scale. The area under the receiver operating characteristic curve (AUC) was used to evaluate the artifact detection performance. At a WW of 100 HU, the AUC (95% confidence interval) was 0.658 (0.576, 0.740), 0.532 (0.429, 0.635), and 0.616 (0.543, 0.619) for the experienced, new, and all technologists, respectively. At a WW of 40 HU, the AUC was 0.768 (0.687, 0.850), 0.546 (0.433, 0.658), and 0.694 (0.619, 0.769), respectively. The performance significantly improved at WW of 40 HU for experienced technologists (p = 0.009) and for all technologists (p = 0.040). Use of a narrow display WW significantly improved technologists' performance in dQC for detecting subtle but clinically relevant artifacts as compared to that using a 100 HU display WW.

  14. Outcome-centered antiepileptic therapy: Rate, rhythm and relief.: Implementing AAN Epilepsy Quality Measures in clinical practice.

    Science.gov (United States)

    D'Cruz, O'Neill

    2015-12-01

    Clinicians who manage patients with epilepsy are expected to assess the relevance of clinical trial results to their practice, integrate new treatments into the care algorithm, and implement epilepsy quality measures, with the overall goal of improving patient outcomes. A disease-based clinical framework that helps with choice and combinations of interventions facilitates provision of efficient, cost-effective, and high-quality care. This article addresses the current conceptual framework that informs clinical evaluation of epilepsy, explores gaps between development of treatment options, quality measures and clinical goals, and proposes an outcome-centered approach that bridges these gaps with the aim of improving patient and population-level clinical outcomes in epilepsy. Copyright © 2015 The Author. Published by Elsevier Inc. All rights reserved.

  15. Prospective early detection of avascular necrosis of the femoral head with MR imaging in high-risk patients: Is it clinically relevant

    International Nuclear Information System (INIS)

    Von Schulthess, G.K.; Binswanger, U.

    1987-01-01

    To evaluate the clinical relevance of early detection of avascular necrosis (AVN) of the femoral head in a high-risk group, the authors performed MR imaging in 16 renal transplant patients receiving prednisone. Imaging was done at 3-month intervals over 8-24 months. Of the 15 patients remaining in the study (one underwent nephrectomy), two have shown clear MR imaging signs of early AVN persisting for 12 months without clinical symptoms. One patient had an abrupt onset of clinically relevant AVN before the second control MR imaging study was done. These results suggest that MR imaging may detect clinically irrelevant AVN, and that even short intervals between examinations may be too long to provide a warning of impending AVN

  16. Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

    Science.gov (United States)

    Lexchin, J; Holbrook, A

    1994-07-01

    To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). Analytic study. All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.

  17. Antecedent thermal injury worsens split-thickness skin graft quality: A clinically relevant porcine model of full-thickness burn, excision and grafting.

    Science.gov (United States)

    Carlsson, Anders H; Rose, Lloyd F; Fletcher, John L; Wu, Jesse C; Leung, Kai P; Chan, Rodney K

    2017-02-01

    Current standard of care for full-thickness burn is excision followed by autologous split-thickness skin graft placement. Skin grafts are also frequently used to cover surgical wounds not amenable to linear closure. While all grafts have potential to contract, clinical observation suggests that antecedent thermal injury worsens contraction and impairs functional and aesthetic outcomes. This study evaluates the impact of antecedent full-thickness burn on split-thickness skin graft scar outcomes and the potential mediating factors. Full-thickness contact burns (100°C, 30s) were created on the backs of anesthetized female Yorkshire Pigs. After seven days, burn eschar was tangentially excised and covered with 12/1000th inch (300μm) split-thickness skin graft. For comparison, unburned wounds were created by sharp excision to fat before graft application. From 7 to 120days post-grafting, planimetric measurements, digital imaging and biopsies for histology, immunohistochemistry and gene expression were obtained. At 120days post-grafting, the Observer Scar Assessment Scale, colorimetry, contour analysis and optical graft height assessments were performed. Twenty-nine porcine wounds were analyzed. All measured metrics of clinical skin quality were significantly worse (pskin graft quality, likely by multiple mechanisms including burn-related inflammation, microscopically inadequate excision, and dysregulation of tissue remodeling. A valid, reliable, clinically relevant model of full-thickness burn, excision and skin replacement therapy has been demonstrated. Future research to enhance quality of skin replacement therapies should be directed toward modulation of inflammation and assessments for complete excision. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  18. Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

    Science.gov (United States)

    Grady, Haiyan; Elder, David; Webster, Gregory K; Mao, Yun; Lin, Yiqing; Flanagan, Talia; Mann, James; Blanchard, Andy; Cohen, Michael J; Lin, Judy; Kesisoglou, Filippos; Hermans, Andre; Abend, Andreas; Zhang, Limin; Curran, David

    2018-01-01

    This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout pharmaceutical product development, registration, commercialization, and beyond. Over the past 3 decades, dissolution testing has evolved from a routine and straightforward test as a component of end-product release into a comprehensive set of tools that the developer can deploy at various stages of the product life cycle. The definitions of commonly used dissolution approaches, how they relate to one another and how they may be applied in modern drug development, and life cycle management is described in this article. Specifically, this article discusses the purpose, advantages, and limitations of quality control, biorelevant, and clinically relevant dissolution methods. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  19. Do mobile clinics provide high-quality antenatal care? A comparison of care delivery, knowledge outcomes and perception of quality of care between fixed and mobile clinics in central Haiti.

    Science.gov (United States)

    Phillips, Erica; Stoltzfus, Rebecca J; Michaud, Lesly; Pierre, Gracia Lionel Fils; Vermeylen, Francoise; Pelletier, David

    2017-10-16

    Antenatal care (ANC) is an important health service for women in developing countries, with numerous proven benefits. Global coverage of ANC has steadily increased over the past 30 years, in part due to increased community-based outreach. However, commensurate improvements in health outcomes such as reductions in the prevalence of maternal anemia and infants born small-for-gestational age have not been achieved, even with increased coverage, indicating that quality of care may be inadequate. Mobile clinics are one community-based strategy used to further improve coverage of ANC, but their quality of care delivery has rarely been evaluated. To determine the quality of care of ANC in central Haiti, we compared adherence to national guidelines between fixed and mobile clinics by performing direct observations of antenatal care consultations and exit interviews with recipients of care using a multi-stage random sampling procedure. Outcome variables were eight components of care, and women's knowledge and perception of care quality. There were significant differences in the predicted proportion or probability of recommended services for four of eight care components, including intake, laboratory examinations, infection control, and supplies, iron folic acid supplements and Tetanus Toxoid vaccine provided to women. These care components were more likely performed in fixed clinics, except for distribution of supplies, iron-folic acid supplements, and Tetanus Toxoid vaccine, more likely provided in mobile clinics. There were no differences between clinic type for the proportion of total physical exam procedures performed, health and communication messages delivered, provider communication or documentation. Women's knowledge about educational topics was poor, but women perceived extremely high quality of care in both clinic models. Although adherence to guidelines differed by clinic type for half of the care components, both clinics had a low percentage of overall services

  20. Searching for Clinically Relevant Biomarkers in Geriatric Oncology.

    Science.gov (United States)

    Katsila, Theodora; Patrinos, George P; Kardamakis, Dimitrios

    2018-01-01

    Ageing, which is associated with a progressive decline and functional deterioration in multiple organ systems, is highly heterogeneous, both inter- and intraindividually. For this, tailored-made theranostics and optimum patient stratification become fundamental, when decision-making in elderly patients is considered. In particular, when cancer incidence and cancer-related mortality and morbidity are taken into account, elderly patient care is a public health concern. In this review, we focus on oncogeriatrics and highlight current opportunities and challenges with an emphasis on the unmet need of clinically relevant biomarkers in elderly cancer patients. We performed a literature search on PubMed and Scopus databases for articles published in English between 2000 and 2017 coupled to text mining and analysis. Considering the top insights, we derived from our literature analysis that information knowledge needs to turn into knowledge growth in oncogeriatrics towards clinically relevant biomarkers, cost-effective practices, updated educational schemes for health professionals (in particular, geriatricians and oncologists), and awareness of ethical issues. We conclude with an interdisciplinary call to omics, geriatricians, oncologists, informatics, and policy-makers communities that Big Data should be translated into decision-making in the clinic.

  1. Valerian: No Evidence for Clinically Relevant Interactions

    Directory of Open Access Journals (Sweden)

    Olaf Kelber

    2014-01-01

    Full Text Available In recent popular publications as well as in widely used information websites directed to cancer patients, valerian is claimed to have a potential of adverse interactions with anticancer drugs. This questions its use as a safe replacement for, for example, benzodiazepines. A review on the interaction potential of preparations from valerian root (Valeriana officinalis L. root was therefore conducted. A data base search and search in a clinical drug interaction data base were conducted. Thereafter, a systematic assessment of publications was performed. Seven in vitro studies on six CYP 450 isoenzymes, on p-glycoprotein, and on two UGT isoenzymes were identified. However, the methodological assessment of these studies did not support their suitability for the prediction of clinically relevant interactions. In addition, clinical studies on various valerian preparations did not reveal any relevant interaction potential concerning CYP 1A2, 2D6, 2E1, and 3A4. Available animal and human pharmacodynamic studies did not verify any interaction potential. The interaction potential of valerian preparations therefore seems to be low and thereby without clinical relevance. We conclude that there is no specific evidence questioning their safety, also in cancer patients.

  2. Clinically relevant determinants of body composition, function and nutritional status as mortality predictors in lung cancer patients.

    Science.gov (United States)

    Kovarik, Miroslav; Hronek, Miloslav; Zadak, Zdenek

    2014-04-01

    Lung cancer belongs to the type of tumors with a relatively high frequency of malnutrition, sarcopenia and cachexia, severe metabolic syndromes related to impairment of physical function and quality of life, resistance to therapy and short survival. Inexpensive and accessible methods of evaluating changes in body composition, physical function and nutrition status are for this reason of great importance for clinical practice to enable the early identification, monitoring, preventing and treatment of these nutritional deficiencies. This could lead to improved outcomes in the quality of life, physical performance and survival of patients with lung cancer. The aim of this article is to summarize the recent knowledge for the use of such methods, their predictability for patient outcomes and an association with other clinically relevant parameters, specifically with lung cancer patients, because such an article collectively describing their practical application in clinical practice is lacking. The interest of this article is in the use of anthropometry, handgrip dynamometry, bioelectrical impedance analysis derived phase angle and nutritional screening questionnaires in lung cancer patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  3. Diagnostic relevance of high field MRI in clinical neuroradiology: the advantages and challenges of driving a sports car

    International Nuclear Information System (INIS)

    Wattjes, Mike P.; Barkhof, Frederik

    2012-01-01

    High field MRI operating at 3 T is increasingly being used in the field of neuroradiology on the grounds that higher magnetic field strength should theoretically lead to a higher diagnostic accuracy in the diagnosis of several disease entities. This Editorial discusses the exhaustive review by Wardlaw and colleagues of research comparing 3 T MRI with 1.5 T MRI in the field of neuroradiology. Interestingly, the authors found no convincing evidence of improved image quality, diagnostic accuracy, or reduced total examination times using 3 T MRI instead of 1.5 T MRI. These findings are highly relevant since a new generation of high field MRI systems operating at 7 T has recently been introduced. (orig.)

  4. Clinical relevance of narrow-band imaging in flexible cystoscopy

    DEFF Research Database (Denmark)

    Drejer, Ditte; Béji, Sami; Munk Nielsen, Anna

    2017-01-01

    urological departments. Patients had either hematuria (n = 483) or known recurrent non-muscle-invasive bladder cancer (NMIBC) (n = 472). High-definition (HD) cystoscopy was performed in white light (WL) and a preliminary clinical decision was made. Then, a second cystoscopy was performed in NBI...... in NBI compared to WL (NBI: 100.0% vs WL: 83.2%, p decision making as a supplement to WL because it yields a significantly higher...... and a conclusive clinical decision was made. A difference between the two decisions that had a clinical impact on the patient was considered clinically relevant. RESULTS: Pathology was found in 216 WL cystoscopies, and additional pathology in 15 NBI cystoscopies (6.9%). Based on NBI, pathology was suspected in 23...

  5. Clinical relevance of findings in trials of CBT for depression

    NARCIS (Netherlands)

    Lepping, P.; Whittington, R.; Sambhi, R.S.; Lane, S.; Poole, R.; Leucht, S.; Cuijpers, P.; McCabe, R.; Waheed, W.

    2017-01-01

    Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We

  6. [A comparison of the most used instruments to assess the quality of clinical learning environments of nursing students].

    Science.gov (United States)

    Nicotera, Raffaella; Altini, Pietro; Dimonte, Valerio

    2017-01-01

    . A comparison of the most used instruments to assess the quality of clinical learning environments of nursing students. A clinical learning environment (CLE) promotes the development of professional competences, of critical and diagnostic reasoning in future nurses, thus the continuous assessment of its quality is pivotal. To describe and compare the most used instruments to measure the nursing students' perception of the quality of CLEs. Six validated questionnaires were identified and compared: CLE (Clinical Learning Environment), CLEDI (Clinical Learning Environment Diagnostic Inventory), SECEE (Student Evaluation of Clinical Education Environment), CLEI (Clinical Learning Environment Inventory), CLES (Clinical Learning Environment and Supervision), CLES+T (Clinical Learning Environment and Supervision plus Teacher nurse). The following elements were described: conceptual framework, psychometric properties, dimensions explored, the more relevant constructs able to guarantee a high quality CLE: relations between students and ward staff; level of involvement of nurse coordinators; inclusion of the student in the ward team, ward climate, involvement of clinical teacher and feedback to the students. The only instrument that explores all the relevant constructs is the CLES+T. The involvement of clinical nurse teacher and nurse coordinator are the less explored dimensions. The questionnaires CLEI, CLES and CLES+T, validated in Italian and used in several learning environments share the following weaknesses: do not assess the feedback offered to the students, the students' satisfaction for the tutoring strategies and the role of different professionals in the students' learning. The analysis of strengths and weaknesses is the basis to start from to devise and validate a new questionnaire.

  7. Clinical relevance of findings in trials of CBT for depression.

    Science.gov (United States)

    Lepping, P; Whittington, R; Sambhi, R S; Lane, S; Poole, R; Leucht, S; Cuijpers, P; McCabe, R; Waheed, W

    2017-09-01

    Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We identified RCTs of CBT that used the Hamilton Rating Scale for Depression (HAMD). HAMD scores were translated into Clinical Global Impression - Change scale (CGI-I) scores to measure clinical relevance. One hundred and seventy datasets from 82 studies were included. The mean percentage HAMD change for treatment arms was 53.66%, and 29.81% for control arms, a statistically significant difference. Combined active therapies showed the biggest improvement on CGI-I score, followed by CBT alone. All active treatments had better than expected HAMD percentage reduction and CGI-I scores. CBT has a clinically relevant effect in depression, with a notional CGI-I score of 2.2, indicating a significant clinical response. The non-specific or placebo effect of being in a psychotherapy trial was a 29% reduction of HAMD. Copyright © 2017. Published by Elsevier Masson SAS.

  8. Exploring Educational Quality and Relevance through Integrating ...

    African Journals Online (AJOL)

    Exploring Educational Quality and Relevance through Integrating Environmental and Social Issues in Science Education. ... However, the new contextualised concept of learning and teaching was applied only to one of them. A post-test was ...

  9. [The concept of quality of life in medicine: its history and current relevance].

    Science.gov (United States)

    Bullinger, Monika

    2014-01-01

    This paper attempts to review 40 years of quality-of-life research. The increasing recognition of the topic is obvious from the number of publications and its representation in academic discussions. Despite a rather weak theoretical foundation, methods of quality-of-life assessment have been developed successfully. Both the number and the quality of assessment tools have increased over the years so that there is now a broad spectrum of instruments for adults and children available, which is used from epidemiological studies to health services research, and especially in quality assurance and comparative benchmarking. Assessment is still underrepresented in clinical trials, which is why only few meta-analyses and reviews are available. Also, implementation of results in recommendations for treatment and in guidelines has just started. Implications for clinical practice also relate to the patient orientation in the physician-patient communication. A future perspective is the widespread use of available instruments, provided that relevant information is gained, which depends on the study design as well as the interpretation and dissemination of results. Consequences for the healthcare systems are expected if improvements in quality of life can be attributed to benefits of treatment and surrounding services. Copyright © 2014. Published by Elsevier GmbH.

  10. Reflections on relevance: Psychotherapy and Psychosomatics in 2004.

    Science.gov (United States)

    Balon, Richard

    2005-01-01

    Relevance of an article is a highly desirable yet hardly predictable quality at the time of its publication. Article relevance is frequently measured by the impact factor of the journal where the article is published. Furthermore, impact factor, citation index and citation analysis are used as a measure of research progress and scientific wealth of a nation. The wisdom and significance of this approach to relevance is debatable and thus discussed here. In 2004, Psychotherapy and Psychosomatics published a variety of articles which, in the author's view, are clinically relevant. Several selected clinically relevant issues reviewed in this article include: the conceptualization of fibromyalgia as a stress disorder; the psychosocial impact and psychosocial interventions in cancer; the impact of alexithymia on patient care; the possible relationship between depression and nutrition (namely intake of folate and pyridoxal phosphate); the significance of hypercoagulability in panic-like anxiety; the questionable value of single isomer drugs, and the relevance and adequacy of clinimetrics versus psychometrics in clinical research. The reviewed issues seem to be relevant to clinical practice, research or both, but also to our critical thinking, and the critical review of the developments in psychiatry and psychology. Copyright 2005 S. Karger AG, Basel.

  11. [Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

    Science.gov (United States)

    Ishibashi, Midori

    2015-01-01

    The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

  12. Which domains of thyroid-related quality of life are most relevant?

    DEFF Research Database (Denmark)

    Watt, Torquil; Hegedüs, Laszlo; Rasmussen, Ase Krogh

    2007-01-01

    To identify how thyroid diseases impact the patients' lives and to select the most relevant quality of life (QoL) issues for a thyroid-specific questionnaire.......To identify how thyroid diseases impact the patients' lives and to select the most relevant quality of life (QoL) issues for a thyroid-specific questionnaire....

  13. Out-of-Field Dose Equivalents Delivered by Passively Scattered Therapeutic Proton Beams for Clinically Relevant Field Configurations

    International Nuclear Information System (INIS)

    Wroe, Andrew; Clasie, Ben; Kooy, Hanne; Flanz, Jay; Schulte, Reinhard; Rosenfeld, Anatoly

    2009-01-01

    Purpose: Microdosimetric measurements were performed at Massachusetts General Hospital, Boston, MA, to assess the dose equivalent external to passively delivered proton fields for various clinical treatment scenarios. Methods and Materials: Treatment fields evaluated included a prostate cancer field, cranial and spinal medulloblastoma fields, ocular melanoma field, and a field for an intracranial stereotactic treatment. Measurements were completed with patient-specific configurations of clinically relevant treatment settings using a silicon-on-insulator microdosimeter placed on the surface of and at various depths within a homogeneous Lucite phantom. The dose equivalent and average quality factor were assessed as a function of both lateral displacement from the treatment field edge and distance downstream of the beam's distal edge. Results: Dose-equivalent value range was 8.3-0.3 mSv/Gy (2.5-60-cm lateral displacement) for a typical prostate cancer field, 10.8-0.58 mSv/Gy (2.5-40-cm lateral displacement) for the cranial medulloblastoma field, 2.5-0.58 mSv/Gy (5-20-cm lateral displacement) for the spinal medulloblastoma field, and 0.5-0.08 mSv/Gy (2.5-10-cm lateral displacement) for the ocular melanoma field. Measurements of external field dose equivalent for the stereotactic field case showed differences as high as 50% depending on the modality of beam collimation. Average quality factors derived from this work ranged from 2-7, with the value dependent on the position within the phantom in relation to the primary beam. Conclusions: This work provides a valuable and clinically relevant comparison of the external field dose equivalents for various passively scattered proton treatment fields

  14. Health-related quality of life of cranial WHO grade I meningioma patients: are current questionnaires relevant?

    Science.gov (United States)

    Zamanipoor Najafabadi, Amir H; Peeters, Marthe C M; Lobatto, Daniel J; Broekman, Marieke L D; Smith, Timothy R; Biermasz, Nienke R; Peerdeman, Saskia M; Peul, Wilco C; Taphoorn, Martin J B; van Furth, Wouter R; Dirven, Linda

    2017-11-01

    The clinical relevance of Health-Related Quality of Life (HRQoL) in meningioma patients has been increasingly acknowledged in recent years. Various questionnaires have been used. However, almost none of these questionnaires has been particularly developed for and/or validated in this patient group. Therefore, the aim of this study was to assess the relevance and comprehensiveness of existing HRQoL questionnaires used in meningioma research and to assess the agreement between patients and health care professionals (HCPs) on the most relevant and important HRQoL issues. A systematic literature search, following the PRISMA statement, was conducted to identify all HRQoL questionnaires used in meningioma research. Semi-structured interviews were organized with patients and HCPs to (1) assess the relevance of all issues covered by the questionnaires (score 0-3: not relevant-highly relevant), (2) assess the ten most important issues, and (3) identify new relevant HRQoL issues. Fourteen different questionnaires were found in the literature, comprising 140 unique issues. Interviews were conducted with 20 patients (median age 57, 71% female) and 10 HCPs (4 neurosurgeons, 2 neurologists, 2 radiotherapists, 1 rehabilitation specialist, 1 neuropsychologist; median experience 13 years). Meningioma patients rated 17-80% of the issues in each of the questionnaires as relevant, HCPs 90-100%. Patients and HCPs agreed on the relevance of only 49 issues (35%, Cohen's kappa: 0.027). Both patients and HCPs considered lack of energy the most important issue. Patients and HCPs suggested five additional relevant issues not covered by current HRQoL questionnaires. Existing HRQoL questionnaires currently used in meningioma patients do not fully cover all relevant issues to these patients. Agreement between patients and HCPs on the relevance of issues was poor. Both findings support the need to develop and validate a meningioma-specific HRQoL questionnaire.

  15. Working Toward Policy-Relevant Air Quality Emissions Scenarios

    Science.gov (United States)

    Holloway, T.

    2010-12-01

    Though much work has been done to develop accurate chemical emission inventories, few publicly available inventories are appropriate for realistic policy analysis. Emissions from the electricity and transportation sectors, in particular, respond in complex ways to policy, technology, and energy use change. Many widely used inventories, such as the EPA National Emissions Inventory, are well-suited for modeling current air quality, but do not have the specificity needed to address "what if?" questions. Changes in electricity demand, fuel prices, new power sources, and emission controls all influence the emissions from regional power production, requiring a plant-by-plant assessment to capture the spatially explicit impacts. Similarly, land use, freight distribution, or driving behavior will yield differentiated transportation emissions for urban areas, suburbs, and rural highways. We here present results from three recent research projects at the University of Wisconsin—Madison, where bottom-up emission inventories for electricity, freight transport, and urban vehicle use were constructed to support policy-relevant air quality research. These three studies include: 1) Using the MyPower electricity dispatch model to calculate emissions and air quality impacts of Renewable Portfolio Standards and other carbon-management strategies; 2) Using advanced vehicle and commodity flow data from the Federal Highway Administration to evaluate the potential to shift commodities from truck to rail (assuming expanded infrastructure), and assess a range of alternative fuel suggestions; and 3) Working with urban planners to connect urban density with vehicle use to evaluate the air quality impacts of smart-growth in major Midwest cities. Drawing on the results of these three studies, and on challenges overcome in their execution, we discuss the current state of policy-relevant emission dataset generation, as well as techniques and attributes that need to be further refined in order

  16. Web 2.0-based crowdsourcing for high-quality gold standard development in clinical natural language processing.

    Science.gov (United States)

    Zhai, Haijun; Lingren, Todd; Deleger, Louise; Li, Qi; Kaiser, Megan; Stoutenborough, Laura; Solti, Imre

    2013-04-02

    A high-quality gold standard is vital for supervised, machine learning-based, clinical natural language processing (NLP) systems. In clinical NLP projects, expert annotators traditionally create the gold standard. However, traditional annotation is expensive and time-consuming. To reduce the cost of annotation, general NLP projects have turned to crowdsourcing based on Web 2.0 technology, which involves submitting smaller subtasks to a coordinated marketplace of workers on the Internet. Many studies have been conducted in the area of crowdsourcing, but only a few have focused on tasks in the general NLP field and only a handful in the biomedical domain, usually based upon very small pilot sample sizes. In addition, the quality of the crowdsourced biomedical NLP corpora were never exceptional when compared to traditionally-developed gold standards. The previously reported results on medical named entity annotation task showed a 0.68 F-measure based agreement between crowdsourced and traditionally-developed corpora. Building upon previous work from the general crowdsourcing research, this study investigated the usability of crowdsourcing in the clinical NLP domain with special emphasis on achieving high agreement between crowdsourced and traditionally-developed corpora. To build the gold standard for evaluating the crowdsourcing workers' performance, 1042 clinical trial announcements (CTAs) from the ClinicalTrials.gov website were randomly selected and double annotated for medication names, medication types, and linked attributes. For the experiments, we used CrowdFlower, an Amazon Mechanical Turk-based crowdsourcing platform. We calculated sensitivity, precision, and F-measure to evaluate the quality of the crowd's work and tested the statistical significance (Pcrowdsourced and traditionally-developed annotations. The agreement between the crowd's annotations and the traditionally-generated corpora was high for: (1) annotations (0.87, F-measure for medication names

  17. [Clinical trial data management and quality metrics system].

    Science.gov (United States)

    Chen, Zhao-hua; Huang, Qin; Deng, Ya-zhong; Zhang, Yue; Xu, Yu; Yu, Hao; Liu, Zong-fan

    2015-11-01

    Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

  18. Electronic health records improve clinical note quality.

    Science.gov (United States)

    Burke, Harry B; Sessums, Laura L; Hoang, Albert; Becher, Dorothy A; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; O'Malley, Patrick G; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

    2015-01-01

    The clinical note documents the clinician's information collection, problem assessment, clinical management, and its used for administrative purposes. Electronic health records (EHRs) are being implemented in clinical practices throughout the USA yet it is not known whether they improve the quality of clinical notes. The goal in this study was to determine if EHRs improve the quality of outpatient clinical notes. A five and a half year longitudinal retrospective multicenter quantitative study comparing the quality of handwritten and electronic outpatient clinical visit notes for 100 patients with type 2 diabetes at three time points: 6 months prior to the introduction of the EHR (before-EHR), 6 months after the introduction of the EHR (after-EHR), and 5 years after the introduction of the EHR (5-year-EHR). QNOTE, a validated quantitative instrument, was used to assess the quality of outpatient clinical notes. Its scores can range from a low of 0 to a high of 100. Sixteen primary care physicians with active practices used QNOTE to determine the quality of the 300 patient notes. The before-EHR, after-EHR, and 5-year-EHR grand mean scores (SD) were 52.0 (18.4), 61.2 (16.3), and 80.4 (8.9), respectively, and the change in scores for before-EHR to after-EHR and before-EHR to 5-year-EHR were 18% (pquality scores significantly improved over the 5-year time interval. The EHR significantly improved the overall quality of the outpatient clinical note and the quality of all its elements, including the core and non-core elements. To our knowledge, this is the first study to demonstrate that the EHR significantly improves the quality of clinical notes. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  19. Subclinical Hypothyroidism in Children and Adolescents: Is It Clinically Relevant?

    Directory of Open Access Journals (Sweden)

    Aneta Gawlik

    2015-01-01

    Full Text Available Although subclinical hypothyroidism (SH is a common clinical problem, its diagnosis tends to be incidental. According to the definition, it should be asymptomatic, only detectable by screening. The presence or coincidence of any symptoms leads to L-thyroxine treatment. The clinical presentation, especially in younger patients with subclinical hypothyroidism, is still under dispute. Accordingly, the aim of this paper was to review the literature from the past seven years. The literature search identified 1,594 potentially relevant articles, of which 24 met the inclusion criteria. Few studies focus on the symptomatology of subclinical hypothyroidism, and most of them analyzed a small number of subjects. A significant correlation was found by some authors between subclinical hypothyroidism and a higher risk of hypertension, dyslipidemia, and migraine. No evidence of the impact of subclinical hypothyroidism on weight, growth velocity, and puberty was revealed. As the quality of most studies is poor and no definite conclusions can be drawn, randomized, large-scale studies in children and adolescents are warranted to determine the best care for patients with SH.

  20. MDMA, methamphetamine, and CYP2D6 pharmacogenetics: what is clinically relevant?

    Directory of Open Access Journals (Sweden)

    Rafael eDe La Torre

    2012-11-01

    Full Text Available In vitro human studies show that the metabolism of most amphetamine-like psychostimulants is regulated by the polymorphic cytochrome P450 isozyme CYP2D6. Two compounds, methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA, were selected as archetypes to discuss the translation and clinical significance of in vitro to in vivo findings. Both compounds were chosen based on their differential interaction with CYP2D6 and their high abuse prevalence in society. Methamphetamine behaves as both a weak substrate and competitive inhibitor of CYP2D6, while MDMA acts as a high affinity substrate and potent mechanism-based inhibitor (MBI of the enzyme. The MBI behavior of MDMA on CYP2D6 implies that subjects, irrespective of their genotype/phenotype, are phenocopied to the poor metabolizer phenotype. The fraction of metabolic clearance regulated by CYP2D6 for both drugs is substantially lower than expected from in vitro studies. Other isoenzymes of cytochrome P450 and a relevant contribution of renal excretion play a part in their clearance. These facts tune down the potential contribution of CYP2D6 polymorphism in the clinical outcomes of both substances. Globally, the clinical relevance of CYP2D6 polymorphism is lower than that predicted by in vitro studies.

  1. Measuring quality in maternal-newborn care: developing a clinical dashboard.

    Science.gov (United States)

    Sprague, Ann E; Dunn, Sandra I; Fell, Deshayne B; Harrold, Joann; Walker, Mark C; Kelly, Sherrie; Smith, Graeme N

    2013-01-01

    Pregnancy, birth, and the early newborn period are times of high use of health care services. As well as opportunities for providing quality care, there are potential missed opportunities for health promotion, safety issues, and increased costs for the individual and the system when quality is not well defined or measured. There has been a need to identify key performance indicators (KPIs) to measure quality care within the provincial maternal-newborn system. We also wanted to provide automated audit and feedback about these KPIs to support quality improvement initiatives in a large Canadian province with approximately 140 000 births per year. We therefore worked to develop a maternal-newborn dashboard to increase awareness about selected KPIs and to inform and support hospitals and care providers about areas for quality improvement. We mapped maternal-newborn data elements to a quality domain framework, sought feedback via survey for the relevance and feasibility of change, and examined current data and the literature to assist in setting provincial benchmarks. Six clinical performance indicators of maternal-newborn quality care were identified and evidence-informed benchmarks were set. A maternal-newborn dashboard with "drill down" capacity for detailed analysis to enhance audit and feedback is now available for implementation. While audit and feedback does not guarantee individuals or institutions will make practice changes and move towards quality improvement, it is an important first step. Practice change and quality improvement will not occur without an awareness of the issues.

  2. Back to the basics: Identifying and addressing underlying challenges in achieving high quality and relevant health statistics for indigenous populations in Canada.

    Science.gov (United States)

    Smylie, Janet; Firestone, Michelle

    Canada is known internationally for excellence in both the quality and public policy relevance of its health and social statistics. There is a double standard however with respect to the relevance and quality of statistics for Indigenous populations in Canada. Indigenous specific health and social statistics gathering is informed by unique ethical, rights-based, policy and practice imperatives regarding the need for Indigenous participation and leadership in Indigenous data processes throughout the spectrum of indicator development, data collection, management, analysis and use. We demonstrate how current Indigenous data quality challenges including misclassification errors and non-response bias systematically contribute to a significant underestimate of inequities in health determinants, health status, and health care access between Indigenous and non-Indigenous people in Canada. The major quality challenge underlying these errors and biases is the lack of Indigenous specific identifiers that are consistent and relevant in major health and social data sources. The recent removal of an Indigenous identity question from the Canadian census has resulted in further deterioration of an already suboptimal system. A revision of core health data sources to include relevant, consistent, and inclusive Indigenous self-identification is urgently required. These changes need to be carried out in partnership with Indigenous peoples and their representative and governing organizations.

  3. Free software to analyse the clinical relevance of drug interactions with antiretroviral agents (SIMARV®) in patients with HIV/AIDS.

    Science.gov (United States)

    Giraldo, N A; Amariles, P; Monsalve, M; Faus, M J

    Highly active antiretroviral therapy has extended the expected lifespan of patients with HIV/AIDS. However, the therapeutic benefits of some drugs used simultaneously with highly active antiretroviral therapy may be adversely affected by drug interactions. The goal was to design and develop a free software to facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. A comprehensive Medline/PubMed database search of drug interactions was performed. Articles that recognized any drug interactions in HIV disease were selected. The publications accessed were limited to human studies in English or Spanish, with full texts retrieved. Drug interactions were analyzed, assessed, and grouped into four levels of clinical relevance according to gravity and probability. Software to systematize the information regarding drug interactions and their clinical relevance was designed and developed. Overall, 952 different references were retrieved and 446 selected; in addition, 67 articles were selected from the citation lists of identified articles. A total of 2119 pairs of drug interactions were identified; of this group, 2006 (94.7%) were drug-drug interactions, 1982 (93.5%) had an identified pharmacokinetic mechanism, and 1409 (66.5%) were mediated by enzyme inhibition. In terms of clinical relevance, 1285 (60.6%) drug interactions were clinically significant in patients with HIV (levels 1 and 2). With this information, a software program that facilitates identification and assessment of the clinical relevance of antiretroviral drug interactions (SIMARV ® ) was developed. A free software package with information on 2119 pairs of antiretroviral drug interactions was designed and developed that could facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Clinically relevant incidental cardiovascular findings in CT examinations; Klinisch relevante kardiovaskulaere Zufallsbefunde bei CT-Untersuchungen

    Energy Technology Data Exchange (ETDEWEB)

    Voigt, P.; Fahnert, J.; Kahn, T.; Surov, A. [Universitaetsklinikum Leipzig, Klinik fuer Diagnostische und Interventionelle Radiologie, Leipzig (Germany); Schramm, D.; Bach, A.G. [Universitaetsklinikum Halle (Saale), Klinik fuer Radiologie, Halle (Germany)

    2017-04-15

    Incidental cardiovascular findings are a frequent phenomenon in computed tomography (CT) examinations. As the result of a dedicated PubMed search this article gives a systemic overview of the current literature on the most important incidental cardiovascular findings, their prevalence and clinical relevance. The majority of incidental cardiovascular findings are of only low clinical relevance; however, highly relevant incidental findings, such as aortic aneurysms, thromboses and thromboembolic events can also occasionally be found, especially in oncology patients. The scans from every CT examination should also be investigated for incidental findings as they can be of decisive importance for the further clinical management of patients, depending on their clinical relevance. (orig.) [German] Inzidentelle kardiovaskulaere Befunde sind ein haeufiges Phaenomen bei CT-Untersuchungen. Mit dieser Arbeit soll nach gezielter PubMed-Recherche ein systematischer Literaturueberblick ueber die wichtigsten kardiovaskulaeren Zufallsbefunde sowie deren Haeufigkeit und klinische Relevanz gegeben werden. Die Mehrzahl der inzidentellen kardiovaskulaeren Befunde sind klinisch nur von untergeordneter Bedeutung, allerdings werden immer wieder auch hochgradig relevante Zufallsbefunde wie beispielsweise Aortenaneurysmata oder - gerade bei onkologischen Patienten - Thrombosen und thrombembolische Ereignisse detektiert. Jede CT-Untersuchung sollte gezielt nach inzidentellen Befunden durchsucht werden, da diese je nach klinischer Relevanz von entscheidender Bedeutung fuer das weitere klinische Management des Patienten sein koennen. (orig.)

  5. [The relevance of clinical risk management].

    Science.gov (United States)

    Gulino, Matteo; Vergallo, Gianluca Montanari; Frati, Paola

    2011-01-01

    Medical activity includes a risk of possible injury or complications for the patients, that should drive the Health Care Institutions to introduce and/ or improve clinical Risk management instruments. Although Italy is still lacking a National project of Clinical Risk Management, a number of efforts have been made by different Italian Regions to introduce instruments of risk management. In addition, most of National Health Care Institutions include actually a Department specifically in charge to manage the clinical risk. Despite the practical difficulties, the results obtained until now suggest that the risk management may represent a useful instrument to contribute to the reduction of errors in clinical conduct. Indeed, the introduction of adequate instruments of prevention and management of clinical risk may help to ameliorate the quality of health care Institution services.

  6. The challenge of quality and relevance in South African education: a ...

    African Journals Online (AJOL)

    Within a changing South African socio-political context, quality education and schooling mean radically ... in education, necessitate a closer look at the role and meaning of quality and relevance in education. ... AJOL African Journals Online.

  7. Blocking Avoidance and Escape Responses: Relations With Clinically Relevant Behaviors

    Directory of Open Access Journals (Sweden)

    Juliana Maria Bubna Popovitz

    Full Text Available Abstract: The current study aims to evaluate the possible effects of interrupting problematic clinically relevant behaviors on the percentage of these responses and of clinical improvement-related responses. Two clients were treated with Functional Analytic Psychotherapy (FAP, alternating two conditions (ABAB. On condition A, procedures to the therapist consisted of responding to the clinical improvement responses, and to description of outside of therapeutic setting behaviors, but therapists were advised to ignore problem behaviors emitted in session. During condition B, therapists followed the same procedures, but they were oriented to block (interrupt problematic responses emitted in session. Results suggest increase in the percentage of problem behaviors during condition B. Results are discussed, highlighting the viability of planning the contingent response the therapist emits to clinically relevant behaviors.

  8. Serumferritin - diagnostic relevance and clinical usefulness

    Energy Technology Data Exchange (ETDEWEB)

    Linkesch, W [Vienna Univ. (Austria). 2. Medizinische Klinik

    1984-01-01

    The introduction of a WHO Standard for serumferritin effected a standardisation of different methods, improving quality and security for clinical routine diagnostic purposes. Therefore the clinical evaluation of serumferritin gained even more importance. For evaluation of iron stores of children, pregnant women, population studies, patients on hemodialysis or patients with rheumatoid arthritis low serumferritin values give safe results. In addition serumferritin is of clinical usefulness in monitoring therapy of both iron deficiency and iron overload. Evaluating a single serumferritin value one should consider the total clinical situation of the patient. As some tumors can produce and secrete serumferritin, e.g. acute myeloblastic leukemia, germ cell tumors, malignant melanoma, serumferritin might be helpful in monitoring the malignant disease. The ongoing characterization of tissue isoferritin, especially acidic isoferritin, may eventually lead to a clinically significant diagnostic marker of neoplasia.

  9. Serumferritin - diagnostic relevance and clinical usefulness

    International Nuclear Information System (INIS)

    Linkesch, W.

    1984-01-01

    The introduction of a WHO Standard for serumferritin effected a standardisation of different methods, improving quality and security for clinical routine diagnostic purposes. Therefore the clinical evaluation of serumferritin gained even more importance. For evaluation of iron stores of children, pregnant women, population studies, patients on hemodialysis or patients with rheumatoid arthritis low serumferritin values give safe results. In addition serumferritin is of clinical usefulness in monitoring therapy of both iron deficiency and iron overload. Evaluating a single serumferritin value on should consider the total clinical situation of the patient. As some tumors can produce and secrete serumferritin, e. g. acute myeloblastic leukemia, germ cell tumors, malignant melanoma, serumferritin might be helpful in monitoring the malignant disease. The ongoing characterization of tissue isoferritin, especially acidic isoferritin, may eventually lead to a clinically significant diagnostic marker of neoplasia. (Author)

  10. What is the clinically relevant change on the ADAS-Cog?

    Science.gov (United States)

    Schrag, Anette; Schott, Jonathan M

    2012-02-01

    To establish the minimal clinically relevant change (MCRC) on the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) for patients with mild Alzheimer's disease (AD). Cohort study. 59 recruiting sites for the Alzheimer's Disease Neuroimaging Initiative. Outpatients with AD in the Alzheimer's Disease Neuroimaging Initiative. The authors applied anchor-based MCRC methodology comparing ADAS-Cog change against clinicians' judgement of clinically relevant worsening between baseline and 6 months in four domains: memory and non-memory cognitive performance; Clinical Dementia Rating Scale; and Functional Assessment Questionnaire. The analysis was repeated for the 6-12-month interval. To support these findings, the authors calculated distribution-based measures including half-baseline SD (1/2 SD) and SEM. 181 patients (baseline ADAS-Cog score 18.5±6.4) had ADAS-Cog data at 0 and 6 months. Those undergoing clinically significant worsening on any of the four anchor questions (n=41-47) had an average ADAS-Cog change of 3.1-3.8 points. Similar results were found for the 177 patients with 6-12-month data. The average 1/2 SD for the baseline ADAS-Cog score was 3.2, and the SEM was 3.7. 3 points decline on the ADAS-Cog may be an appropriate MCRC for clinical trials of patients with early AD. However, further studies assessing the MCRC for improvement on the ADAS-Cog, using patient-based judgement as an anchor, and determining the minimal clinically relevant difference between change on two treatments are required. http://clinicalTrials.gov Identifier: NCT00106899.

  11. High-angle scattering events strongly affect light collection in clinically relevant measurement geometries for light transport through tissue

    International Nuclear Information System (INIS)

    Canpolat, M.; Mourant, J.R.

    2000-01-01

    Measurement of light transport in tissue has the potential to be an inexpensive and practical tool for non-invasive tissue diagnosis in medical applications because it can provide information on both morphological and biochemical properties. To capitalize on the potential of light transport as a diagnostic tool, an understanding of what information can be gleaned from light transport measurements is needed. We present data concerning the sensitivity of light transport measurements, made in clinically relevant geometries, to scattering properties. The intensity of the backscattered light at small source-detector separations is shown to be sensitive to the phase function, and furthermore the collected light intensity is found to be correlated with the amount of high-angle scattering in the medium. (author)

  12. Retrieval of diagnostic and treatment studies for clinical use through PubMed and PubMed's Clinical Queries filters.

    Science.gov (United States)

    Lokker, Cynthia; Haynes, R Brian; Wilczynski, Nancy L; McKibbon, K Ann; Walter, Stephen D

    2011-01-01

    Clinical Queries filters were developed to improve the retrieval of high-quality studies in searches on clinical matters. The study objective was to determine the yield of relevant citations and physician satisfaction while searching for diagnostic and treatment studies using the Clinical Queries page of PubMed compared with searching PubMed without these filters. Forty practicing physicians, presented with standardized treatment and diagnosis questions and one question of their choosing, entered search terms which were processed in a random, blinded fashion through PubMed alone and PubMed Clinical Queries. Participants rated search retrievals for applicability to the question at hand and satisfaction. For treatment, the primary outcome of retrieval of relevant articles was not significantly different between the groups, but a higher proportion of articles from the Clinical Queries searches met methodologic criteria (p=0.049), and more articles were published in core internal medicine journals (p=0.056). For diagnosis, the filtered results returned more relevant articles (p=0.031) and fewer irrelevant articles (overall retrieval less, p=0.023); participants needed to screen fewer articles before arriving at the first relevant citation (p<0.05). Relevance was also influenced by content terms used by participants in searching. Participants varied greatly in their search performance. Clinical Queries filtered searches returned more high-quality studies, though the retrieval of relevant articles was only statistically different between the groups for diagnosis questions. Retrieving clinically important research studies from Medline is a challenging task for physicians. Methodological search filters can improve search retrieval.

  13. Automatic classification and detection of clinically relevant images for diabetic retinopathy

    Science.gov (United States)

    Xu, Xinyu; Li, Baoxin

    2008-03-01

    We proposed a novel approach to automatic classification of Diabetic Retinopathy (DR) images and retrieval of clinically-relevant DR images from a database. Given a query image, our approach first classifies the image into one of the three categories: microaneurysm (MA), neovascularization (NV) and normal, and then it retrieves DR images that are clinically-relevant to the query image from an archival image database. In the classification stage, the query DR images are classified by the Multi-class Multiple-Instance Learning (McMIL) approach, where images are viewed as bags, each of which contains a number of instances corresponding to non-overlapping blocks, and each block is characterized by low-level features including color, texture, histogram of edge directions, and shape. McMIL first learns a collection of instance prototypes for each class that maximizes the Diverse Density function using Expectation- Maximization algorithm. A nonlinear mapping is then defined using the instance prototypes and maps every bag to a point in a new multi-class bag feature space. Finally a multi-class Support Vector Machine is trained in the multi-class bag feature space. In the retrieval stage, we retrieve images from the archival database who bear the same label with the query image, and who are the top K nearest neighbors of the query image in terms of similarity in the multi-class bag feature space. The classification approach achieves high classification accuracy, and the retrieval of clinically-relevant images not only facilitates utilization of the vast amount of hidden diagnostic knowledge in the database, but also improves the efficiency and accuracy of DR lesion diagnosis and assessment.

  14. Two clinically relevant pressures of carbon dioxide pneumoperitoneum cause hepatic injury in a rabbit model

    OpenAIRE

    Li, Jun; Liu, Ying-Hai; Ye, Zhan-Yong; Liu, He-Nian; Ou, Shan; Tian, Fu-Zhou

    2011-01-01

    AIM: To observe the hepatic injury induced by carbon dioxide pneumoperitoneum (CDP) in rabbits, compare the effects of low- and high-pressure pneumoperitoneum, and to determine the degree of hepatic injury induced by these two clinically relevant CDP pressures.

  15. Clinically relevant potential drug-drug interactions among outpatients: A nationwide database study.

    Science.gov (United States)

    Jazbar, Janja; Locatelli, Igor; Horvat, Nejc; Kos, Mitja

    2018-06-01

    Adverse drug events due to drug-drug interactions (DDIs) represent a considerable public health burden, also in Slovenia. A better understanding of the most frequently occurring potential DDIs may enable safer pharmacotherapy and minimize drug-related problems. The aim of this study was to evaluate the prevalence and predictors of potential DDIs among outpatients in Slovenia. An analysis of potential DDIs was performed using health claims data on prescription drugs from a nationwide database. The Lexi-Interact Module was used as the reference source of interactions. The influence of patient-specific predictors on the risk of potential clinically relevant DDIs was evaluated using logistic regression model. The study population included 1,179,803 outpatients who received 15,811,979 prescriptions. The total number of potential DDI cases identified was 3,974,994, of which 15.6% were potentially clinically relevant. Altogether, 9.3% (N = 191,213) of the total population in Slovenia is exposed to clinically relevant potential DDIs, and the proportion is higher among women and the elderly. After adjustment for cofactors, higher number of medications and older age are associated with higher odds of clinically relevant potential DDIs. The burden of DDIs is highest with drug combinations that increase risk of bleeding, enhance CNS depression or anticholinergic effects or cause cardiovascular complications. The current study revealed that 1 in 10 individuals in the total Slovenian population is exposed to clinically relevant potential DDIs yearly. Taking into account the literature based conservative estimate that approximately 1% of potential DDIs result in negative health outcomes, roughly 1800 individuals in Slovenia experience an adverse health outcome each year as a result of clinically relevant potential interactions alone. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Improving the quality of nurse clinical documentation for chronic patients at primary care clinics: A multifaceted intervention.

    Science.gov (United States)

    Mahomed, Ozayr H; Naidoo, Salsohni; Asmall, Shaidah; Taylor, Myra

    2015-09-25

    Deficiencies in record keeping practices have been reported at primary care level in the public health sector in South Africa. These deficiencies have the potential to negatively impact patient health outcomes as the break in information may hinder continuity of care. This disruption in information management has particular relevance for patients with chronic diseases. The aim of this study was to establish if the implementation of a structured clinical record (SCR) as an adjunct tool to the algorithmic guidelines for chronic disease management improved the quality of clinical records at primary care level. A quasi-experimental study (before and after study with a comparison group) was conducted across 30 primary health care clinics (PHCs) located in three districts in South Africa. Twenty PHCs that received the intervention were selected as intervention clinics and 10 facilities were selected as comparison facilities. The lot quality assurance sampling (LQAS) method was used to determine the number of records required to be reviewed per diagnostic condition per facility. There was a a statistically significant increase in the percentage of clinical records achieving compliance to the minimum criteria from the baseline to six months post-intervention for both HIV patients on antiretroviral treatment and patients with non-communicable diseases (hypertension and diabetes). A multifaceted intervention using a SCR to supplement the educational outreach component (PC 101 training) has demonstrated the potential for improving the quality of clinical records for patients with chronic diseases at primary care clinics in South Africa.

  17. A rule-based electronic phenotyping algorithm for detecting clinically relevant cardiovascular disease cases.

    Science.gov (United States)

    Esteban, Santiago; Rodríguez Tablado, Manuel; Ricci, Ricardo Ignacio; Terrasa, Sergio; Kopitowski, Karin

    2017-07-14

    The implementation of electronic medical records (EMR) is becoming increasingly common. Error and data loss reduction, patient-care efficiency increase, decision-making assistance and facilitation of event surveillance, are some of the many processes that EMRs help improve. In addition, they show a lot of promise in terms of data collection to facilitate observational epidemiological studies and their use for this purpose has increased significantly over the recent years. Even though the quantity and availability of the data are clearly improved thanks to EMRs, still, the problem of the quality of the data remains. This is especially important when attempting to determine if an event has actually occurred or not. We sought to assess the sensitivity, specificity, and agreement level of a codes-based algorithm for the detection of clinically relevant cardiovascular (CaVD) and cerebrovascular (CeVD) disease cases, using data from EMRs. Three family physicians from the research group selected clinically relevant CaVD and CeVD terms from the international classification of primary care, Second Edition (ICPC-2), the ICD 10 version 2015 and SNOMED-CT 2015 Edition. These terms included both signs, symptoms, diagnoses and procedures associated with CaVD and CeVD. Terms not related to symptoms, signs, diagnoses or procedures of CaVD or CeVD and also those describing incidental findings without clinical relevance were excluded. The algorithm yielded a positive result if the patient had at least one of the selected terms in their medical records, as long as it was not recorded as an error. Else, if no terms were found, the patient was classified as negative. This algorithm was applied to a randomly selected sample of the active patients within the hospital's HMO by 1/1/2005 that were 40-79 years old, had at least one year of seniority in the HMO and at least one clinical encounter. Thus, patients were classified into four groups: (1) Negative patients (2) Patients with Ca

  18. Service quality framework for clinical laboratories.

    Science.gov (United States)

    Ramessur, Vinaysing; Hurreeram, Dinesh Kumar; Maistry, Kaylasson

    2015-01-01

    The purpose of this paper is to illustrate a service quality framework that enhances service delivery in clinical laboratories by gauging medical practitioner satisfaction and by providing avenues for continuous improvement. The case study method has been used for conducting the exploratory study, with focus on the Mauritian public clinical laboratory. A structured questionnaire based on the SERVQUAL service quality model was used for data collection, analysis and for the development of the service quality framework. The study confirms the pertinence of the following service quality dimensions within the context of clinical laboratories: tangibility, reliability, responsiveness, turnaround time, technology, test reports, communication and laboratory staff attitude and behaviour. The service quality framework developed, termed LabSERV, is vital for clinical laboratories in the search for improving service delivery to medical practitioners. This is a pioneering work carried out in the clinical laboratory sector in Mauritius. Medical practitioner expectations and perceptions have been simultaneously considered to generate a novel service quality framework for clinical laboratories.

  19. Evaluating the Quality of Veterinary Students' Experiences of Learning in Clinics.

    Science.gov (United States)

    Matthew, Susan M; Ellis, Robert A; Taylor, Rosanne M

    Educators seeking to evaluate the quality of students' experiences of clinic-based learning (CBL) face a challenging task. CBL programs provide multiple opportunities for learning and aim to develop a wide range of skills, knowledge, and capacities. While direct observation of learners provides important information about students' proficiency in performing various clinical tasks, more comprehensive measures are required to unpack and identify factors relating to practice readiness as a whole. This study identified variables that have a logical and statistically significant association with learning outcomes across the broad range of attributes expected of new graduate veterinarians. The research revealed that the extent of final-year veterinary students' practice readiness, as assessed by placement supervisors against criteria relevant to new graduate practice, is related to the quality of their conceptions of and approaches to CBL. Students' conceptions of and approaches to CBL were evaluated using quantitative survey instruments, with a 93% response rate (N=100) obtained for the two questionnaires. Descriptive and exploratory statistics were used to link qualitative differences in students' conceptions of and approaches to CBL with performance against criteria relevant to new graduate practice. Students who reported poorer-quality conceptions of and approaches to CBL (n=38) attained lower levels of achievement than students who reported better-quality conceptions of and approaches to CBL (n=55). Evaluation of students' conceptions of and approaches to CBL can be used by educators seeking to evaluate and improve the extent to which CBL programs are achieving their desired goals.

  20. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality.

    Directory of Open Access Journals (Sweden)

    Belinda von Niederhäusern

    Full Text Available To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research.We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes.Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives.Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across

  1. Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality

    Science.gov (United States)

    von Niederhäusern, Belinda; Schandelmaier, Stefan; Mi Bonde, Marie; Brunner, Nicole; Hemkens, Lars G.; Rutquist, Marielle; Bhatnagar, Neera; Guyatt, Gordon H.; Pauli-Magnus, Christiane; Briel, Matthias

    2017-01-01

    Objective To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. Study design and setting We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015. Stakeholders included governmental bodies, regulatory agencies, the pharmaceutical industry, academic and commercial contract research organizations, initiatives, research ethics committees, patient organizations and funding agencies from 13 countries. Data synthesis involved descriptive and qualitative analyses following the Framework Method on definitions, concepts, and criteria of clinical research quality. Descriptive codes were applied and grouped into clusters to identify common and stakeholder-specific quality themes. Results Stakeholder concepts on how to assure quality throughout study conduct or articles on quality assessment tools were common, generally with no a priori definition of the term quality itself. We identified a total of 20 explicit definitions of clinical research quality including varying quality dimensions and focusing on different stages in the clinical research process. Encountered quality dimensions include ethical conduct, patient safety/rights/priorities, internal validity, precision of results, generalizability or external validity, scientific and societal relevance, transparency and accessibility of information, research infrastructure and sustainability. None of the definitions appeared to be comprehensive either in terms of quality dimensions, research stages, or stakeholder perspectives. Conclusion Clinical research quality is often discussed but rarely defined. A framework defining

  2. Using mixed methods to identify and answer clinically relevant research questions.

    Science.gov (United States)

    Shneerson, Catherine L; Gale, Nicola K

    2015-06-01

    The need for mixed methods research in answering health care questions is becoming increasingly recognized because of the complexity of factors that affect health outcomes. In this article, we argue for the value of using a qualitatively driven mixed method approach for identifying and answering clinically relevant research questions. This argument is illustrated by findings from a study on the self-management practices of cancer survivors and the exploration of one particular clinically relevant finding about higher uptake of self-management in cancer survivors who had received chemotherapy treatment compared with those who have not. A cross-sectional study generated findings that formed the basis for the qualitative study, by informing the purposive sampling strategy and generating new qualitative research questions. Using a quantitative research component to supplement a qualitative study can enhance the generalizability and clinical relevance of the findings and produce detailed, contextualized, and rich answers to research questions that would be unachievable through quantitative or qualitative methods alone. © The Author(s) 2015.

  3. Classification of first branchial cleft anomalies: is it clinically relevant ...

    African Journals Online (AJOL)

    Background: There are three classification systems for first branchial cleft anomalies currently in use. The Arnot, Work and Olsen classifications describe these lesions on the basis of morphology, tissue of origin and clinical appearance. However, the clinical relevance of these classifications is debated, as they may not be ...

  4. The clinical relevance and newsworthiness of NIHR HTA-funded research: a cohort study.

    Science.gov (United States)

    Wright, D; Young, A; Iserman, E; Maeso, R; Turner, S; Haynes, R B; Milne, R

    2014-05-07

    To assess the clinical relevance and newsworthiness of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme funded reports. Retrospective cohort study. The cohort included 311 NIHR HTA Programme funded reports publishing in HTA in the period 1 January 2007-31 December 2012. The McMaster Online Rating of Evidence (MORE) system independently identified the clinical relevance and newsworthiness of NIHR HTA publications and non-NIHR HTA publications. The MORE system involves over 4000 physicians rating publications on a scale of relevance (the extent to which articles are relevant to practice) and a scale of newsworthiness (the extent to which articles contain news or something clinicians are unlikely to know). The proportion of reports published in HTA meeting MORE inclusion criteria and mean average relevance and newsworthiness ratings were calculated and compared with publications from the same studies publishing outside HTA and non-NIHR HTA funded publications. 286/311 (92.0%) of NIHR HTA reports were assessed by MORE, of which 192 (67.1%) passed MORE criteria. The average clinical relevance rating for NIHR HTA reports was 5.48, statistically higher than the 5.32 rating for non-NIHR HTA publications (mean difference=0.16, 95% CI 0.04 to 0.29, p=0.01). Average newsworthiness ratings were similar between NIHR HTA reports and non-NIHR HTA publications (4.75 and 4.70, respectively; mean difference=0.05, 95% CI -0.18 to 0.07, p=0.402). NIHR HTA-funded original research reports were statistically higher for newsworthiness than reviews (5.05 compared with 4.64) (mean difference=0.41, 95% CI 0.18 to 0.64, p=0.001). Funding research of clinical relevance is important in maximising the value of research investment. The NIHR HTA Programme is successful in funding projects that generate outputs of clinical relevance.

  5. Quality improvement in clinical documentation: does clinical governance work?

    Directory of Open Access Journals (Sweden)

    Dehghan M

    2013-12-01

    Full Text Available Mahlegha Dehghan,1 Dorsa Dehghan,2 Akbar Sheikhrabori,3 Masoume Sadeghi,4 Mehrdad Jalalian5 1Department of Medical Surgical Nursing, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, 2Department of Pediatric Nursing, School of Nursing and Midwifery, Islamic Azad University Kerman Branch, Kerman, 3Department of Medical Surgical Nursing, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, 4Research Center for Modeling in Health, Institute of Futures Studies in Health, Kerman University of Medical Sciences, Kerman, 5Electronic Physician Journal, Mashhad, Iran Introduction: The quality of nursing documentation is still a challenge in the nursing profession and, thus, in the health care industry. One major quality improvement program is clinical governance, whose mission is to continuously improve the quality of patient care and overcome service quality problems. The aim of this study was to identify whether clinical governance improves the quality of nursing documentation. Methods: A quasi-experimental method was used to show nursing documentation quality improvement after a 2-year clinical governance implementation. Two hundred twenty random nursing documents were assessed structurally and by content using a valid and reliable researcher made checklist. Results: There were no differences between a nurse's demographic data before and after 2 years (P>0.05 and the nursing documentation score did not improve after a 2-year clinical governance program. Conclusion: Although some efforts were made to improve nursing documentation through clinical governance, these were not sufficient and more attempts are needed. Keywords: nursing documentation, clinical governance, quality improvement, nursing record

  6. Improving the quality of nurse clinical documentation for chronic patients at primary care clinics: A multifaceted intervention

    Directory of Open Access Journals (Sweden)

    Ozayr H. Mahomed

    2015-09-01

    Full Text Available Background: Deficiencies in record keeping practices have been reported at primary care level in the public health sector in South Africa. These deficiencies have the potential to negatively impact patient health outcomes as the break in information may hinder continuity of care. This disruption in information management has particular relevance for patients with chronic diseases. Objectives: The aim of this study was to establish if the implementation of a structured clinical record (SCR as an adjunct tool to the algorithmic guidelines for chronic disease management improved the quality of clinical records at primary care level. Method: A quasi-experimental study (before and after study with a comparison group was conducted across 30 primary health care clinics (PHCs located in three districts in South Africa. Twenty PHCs that received the intervention were selected as intervention clinics and 10 facilities were selected as comparison facilities. The lot quality assurance sampling (LQAS method was used to determine the number of records required to be reviewed per diagnostic condition per facility. Results: There was a a statistically significant increase in the percentage of clinical records achieving compliance to the minimum criteria from the baseline to six months post-intervention for both HIV patients on antiretroviral treatment and patients with non-communicable diseases (hypertension and diabetes. Conclusions: A multifaceted intervention using a SCR to supplement the educational outreach component (PC 101 training has demonstrated the potential for improving the quality of clinical records for patients with chronic diseases at primary care clinics in South Africa.

  7. Education in the clinical context: establishing a strategic framework to ensure relevance.

    Science.gov (United States)

    Henderson, Amanda; Fox, Robyn; Armit, Lyn

    2008-01-01

    Quality contemporary practice relies on nurses to provide health care within an embedded nexus of clinical, professional and organisational learning that leads them through a career trajectory that encourages lifelong development. Within complex health service environments this is fraught with difficulties. Enhancing practice is multifaceted requiring not just education for the acquisition of skills and abilities but time and space for reflection on experience within the clinical context. This ultimately leads to professional knowledge development. Queensland Health has developed a Nursing and Midwifery Staff Development Framework to assist nurses in structuring their experiences in the practice setting to enable their professional goals. Learning is guided within this framework through its collective modus operandi, that is, the development of teams that overlap to identify and progress the educational agenda; resources to develop consistent relevant learning material that incorporates evidence obtained through practices and the literature; and educator and clinician networks across health services throughout the state, and furthermore, links with the tertiary sector to assist in marketing, applicability and synergy with further education.

  8. Diagnosing congenital malaria in a high-transmission setting: clinical relevance and usefulness of P.falciparum HRP2-based testing

    NARCIS (Netherlands)

    Natama, Hamtandi Magloire; Ouedraogo, Delwendé Florence; Sorgho, Hermann; Rovira-Vallbona, Eduard; Serra-Casas, Elisa; Somé, M. Athanase; Coulibaly-Traoré, Maminata; Mens, Petra F.; Kestens, Luc; Tinto, Halidou; Rosanas-Urgell, Anna

    2017-01-01

    Congenital malaria diagnosis is challenging due to frequently observed low parasite density infections, while their clinical relevance during early infancy is not well characterized. In Nanoro health district (Burkina Faso), we determined the prevalence of congenital malaria by real-time

  9. Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics

    Directory of Open Access Journals (Sweden)

    Danbo Yang

    2010-12-01

    Full Text Available The concept of utilizing polymers in drug delivery has been extensively explored for improving the therapeutic index of small molecule drugs. In general, polymers can be used as polymer-drug conjugates or polymeric micelles. Each unique application mandates its own chemistry and controlled release of active drugs. Each polymer exhibits its own intrinsic issues providing the advantage of flexibility. However, none have as yet been approved by the U.S. Food and Drug Administration. General aspects of polymer and nano-particle therapeutics have been reviewed. Here we focus this review on specific clinically relevant anticancer polymer paclitaxel therapeutics. We emphasize their chemistry and formulation, in vitro activity on some human cancer cell lines, plasma pharmacokinetics and tumor accumulation, in vivo efficacy, and clinical outcomes. Furthermore, we include a short review of our recent developments of a novel poly(L-g-glutamylglutamine-paclitaxel nano-conjugate (PGG-PTX. PGG-PTX has its own unique property of forming nano-particles. It has also been shown to possess a favorable profile of pharmacokinetics and to exhibit efficacious potency. This review might shed light on designing new and better polymer paclitaxel therapeutics for potential anticancer applications in the clinic.

  10. Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics

    International Nuclear Information System (INIS)

    Yang, Danbo; Yu, Lei; Van, Sang

    2010-01-01

    The concept of utilizing polymers in drug delivery has been extensively explored for improving the therapeutic index of small molecule drugs. In general, polymers can be used as polymer-drug conjugates or polymeric micelles. Each unique application mandates its own chemistry and controlled release of active drugs. Each polymer exhibits its own intrinsic issues providing the advantage of flexibility. However, none have as yet been approved by the U.S. Food and Drug Administration. General aspects of polymer and nano-particle therapeutics have been reviewed. Here we focus this review on specific clinically relevant anticancer polymer paclitaxel therapeutics. We emphasize their chemistry and formulation, in vitro activity on some human cancer cell lines, plasma pharmacokinetics and tumor accumulation, in vivo efficacy, and clinical outcomes. Furthermore, we include a short review of our recent developments of a novel poly(l-γ-glutamylglutamine)-paclitaxel nano-conjugate (PGG-PTX). PGG-PTX has its own unique property of forming nano-particles. It has also been shown to possess a favorable profile of pharmacokinetics and to exhibit efficacious potency. This review might shed light on designing new and better polymer paclitaxel therapeutics for potential anticancer applications in the clinic

  11. Clinically Relevant Anticancer Polymer Paclitaxel Therapeutics

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Danbo [Biomedical Engineering and Technology Institute, Institutes for Advanced Interdisciplinary Research, East China Normal University, 3663 North Zhongshan Road, Shanghai, 200062 (China); Yu, Lei, E-mail: yu-lei@gg.nitto.co.jp [Biomedical Engineering and Technology Institute, Institutes for Advanced Interdisciplinary Research, East China Normal University, 3663 North Zhongshan Road, Shanghai, 200062 (China); Biomedical Group, Nitto Denko Technical Corporation, 501 Via Del Monte, Oceanside, CA 92058 (United States); Van, Sang [Biomedical Group, Nitto Denko Technical Corporation, 501 Via Del Monte, Oceanside, CA 92058 (United States)

    2010-12-23

    The concept of utilizing polymers in drug delivery has been extensively explored for improving the therapeutic index of small molecule drugs. In general, polymers can be used as polymer-drug conjugates or polymeric micelles. Each unique application mandates its own chemistry and controlled release of active drugs. Each polymer exhibits its own intrinsic issues providing the advantage of flexibility. However, none have as yet been approved by the U.S. Food and Drug Administration. General aspects of polymer and nano-particle therapeutics have been reviewed. Here we focus this review on specific clinically relevant anticancer polymer paclitaxel therapeutics. We emphasize their chemistry and formulation, in vitro activity on some human cancer cell lines, plasma pharmacokinetics and tumor accumulation, in vivo efficacy, and clinical outcomes. Furthermore, we include a short review of our recent developments of a novel poly(l-γ-glutamylglutamine)-paclitaxel nano-conjugate (PGG-PTX). PGG-PTX has its own unique property of forming nano-particles. It has also been shown to possess a favorable profile of pharmacokinetics and to exhibit efficacious potency. This review might shed light on designing new and better polymer paclitaxel therapeutics for potential anticancer applications in the clinic.

  12. Process-based quality management for clinical implementation of adaptive radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Noel, Camille E.; Santanam, Lakshmi; Parikh, Parag J.; Mutic, Sasa, E-mail: smutic@radonc.wustl.edu [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri 63110 (United States)

    2014-08-15

    Purpose: Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. Methods: An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical. Results: FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Conclusions: Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily

  13. Process-based quality management for clinical implementation of adaptive radiotherapy

    International Nuclear Information System (INIS)

    Noel, Camille E.; Santanam, Lakshmi; Parikh, Parag J.; Mutic, Sasa

    2014-01-01

    Purpose: Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. Methods: An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical. Results: FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Conclusions: Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily

  14. Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare.

    Science.gov (United States)

    Tozzo, Pamela; Mazzi, Anna; Aprile, Anna; Rodriguez, Daniele; Caenazzo, Luciana

    2018-03-24

    This paper refers to the quality management process of the Laboratory of Clinical Bioethics (LCB) of the University of Padua (Italy), which has obtained the quality certification to ISO 9001:2008, as a Clinical Ethics Support Service. Its activities consist mainly in clinical ethics consultations and training services, addressed to those who are called to decisions with ethical implications in the clinical setting, proposing a structured approach to identify and analyze the ethical issues that may loom in the relationships between health professionals and patients, and participating in their solution. The expected benefits of the application of ISO 9001 were mainly the following: to formalize the procedure adopted for clinical ethics consultation and training, to obtain a controlled management of documents, information and data, to ensure and demonstrate the quality of the provided activities and to make methods and organization publicly available. The main results which have been achieved with the 'quality management project' are summarized as follows: the enunciation of LCB Mission and Quality Policy; the drafting of the procedure by which clinical ethics consultation is provided; the formalization of members' skills and the adoption of relevant process and outcome indicators. Our experience may be useful in promoting accountability for the quality of ethics consultation services. We consider the certification process as a tool for transparent and reliable management of one of the most critical tasks in the current context of healthcare, motivating similar facilities to undertake similar pathways, with the aim to provide quality control on their activities.

  15. Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

    Science.gov (United States)

    Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

    2016-01-01

    Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Extracellular membrane vesicles in blood products-biology and clinical relevance

    Directory of Open Access Journals (Sweden)

    Emilija Krstova Krajnc

    2016-01-01

    Full Text Available Extracellular membrane vesicles are fragments shed from plasma membranes off all cell types that are undergoing apoptosis or are being subjected to various types of stimulation or stress.  Even in the process of programmed cell death (apoptosis, cell fall apart of varying size vesicles. They expose phosphatidylserine (PS on the outer leaflet of their membrane, and bear surface membrane antigens reflecting their cellular origin. Extracellular membrane vesicles have been isolated from many types of biological fluids, including serum, cerebrospinal fluid, urine, saliva, tears and conditioned culture medium. Flow cytometry is one of the many different methodological approaches that have been used to analyze EMVs. The method attempts to characterize the EMVs cellular origin, size, population, number, and structure. EMVs are present and accumulate in blood products (erythrocytes, platelets as well as in fresh frozen plasma during storage. The aim of this review is to highlight the importance of extracellular vesicles as a cell-to-cell communication system and the role in the pathogenesis of different diseases. Special emphasis will be given to the implication of extracellular membrane vesicles in blood products and their clinical relevance. Although our understanding of the role of  EMVs in disease is far from comprehensive, they display promise as biomarkers for different diseases in the future and also as a marker of quality and safety in the quality control of blood products.

  17. Mild obstructive sleep apnoea: clinical relevance and approaches to management.

    Science.gov (United States)

    McNicholas, Walter T; Bonsignore, Maria R; Lévy, Patrick; Ryan, Silke

    2016-10-01

    Obstructive sleep apnoea is highly prevalent in the general population worldwide, especially in its mild form. Clinical manifestations correlate poorly with disease severity measured by the apnoea-hypopnoea index (AHI), which complicates diagnosis. Full polysomnography might be more appropriate to assess suspected mild cases because limited ambulatory diagnostic systems are least accurate in mild disease. Treatment options in mild obstructive sleep apnoea include continuous positive airway pressure (CPAP) and oral appliance therapy, in addition to positional therapy and weight reduction when appropriate. The superior efficacy of CPAP in reducing AHI is offset by greater tolerance of oral appliances, especially in mild disease. Although severe obstructive sleep apnoea is associated with adverse health consequences, including cardiometabolic comorbidities, the association with mild disease is unclear, and reports differ regarding the clinical relevance of mild obstructive sleep apnoea. Improved diagnostic techniques and evidence-based approaches to management in mild obstructive sleep apnoea require further research. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. High-quality cardiopulmonary resuscitation: current and future directions.

    Science.gov (United States)

    Abella, Benjamin S

    2016-06-01

    Cardiopulmonary resuscitation (CPR) represents the cornerstone of cardiac arrest resuscitation care. Prompt delivery of high-quality CPR can dramatically improve survival outcomes; however, the definitions of optimal CPR have evolved over several decades. The present review will discuss the metrics of CPR delivery, and the evidence supporting the importance of CPR quality to improve clinical outcomes. The introduction of new technologies to quantify metrics of CPR delivery has yielded important insights into CPR quality. Investigations using CPR recording devices have allowed the assessment of specific CPR performance parameters and their relative importance regarding return of spontaneous circulation and survival to hospital discharge. Additional work has suggested new opportunities to measure physiologic markers during CPR and potentially tailor CPR delivery to patient requirements. Through recent laboratory and clinical investigations, a more evidence-based definition of high-quality CPR continues to emerge. Exciting opportunities now exist to study quantitative metrics of CPR and potentially guide resuscitation care in a goal-directed fashion. Concepts of high-quality CPR have also informed new approaches to training and quality improvement efforts for cardiac arrest care.

  19. Chiral drug analysis using mass spectrometric detection relevant to research and practice in clinical and forensic toxicology.

    Science.gov (United States)

    Schwaninger, Andrea E; Meyer, Markus R; Maurer, Hans H

    2012-12-21

    This paper reviews analytical approaches published in 2002-2012 for chiral drug analysis and their relevance in research and practice in the field of clinical and forensic toxicology. Separation systems such as gas chromatography, high performance liquid chromatography, capillary electromigration, and supercritical fluid chromatography, all coupled to mass spectrometry, are discussed. Typical applications are reviewed for relevant chiral analytes such as amphetamines and amphetamine-derived designer drugs, methadone, tramadol, psychotropic and other CNS acting drugs, anticoagulants, cardiovascular drugs, and some other drugs. Usefulness of chiral drug analysis in the interpretation of analytical results in clinical and forensic toxicology is discussed as well. Copyright © 2012 Elsevier B.V. All rights reserved.

  20. Evaluation of service quality in family planning clinics in Lusaka, Zambia.

    Science.gov (United States)

    Hancock, Nancy L; Vwalika, Bellington; Sitali, Elizabeth Siyama; Mbwili-Muleya, Clara; Chi, Benjamin H; Stuart, Gretchen S

    2015-10-01

    To determine the quality of contraceptive services in family planning clinics in Lusaka, Zambia, using a standardized approach. We utilized the Quick Investigation of Quality, a cross-sectional survey tool consisting of a facility assessment, client-provider observation and client exit interview, in public-sector family planning clinics. Data were collected on availability of seven contraceptive methods, information given to clients, interpersonal relations between providers and clients, providers' technical competence and mechanisms for continuity and follow-up. Data were collected from five client-provider observations and client exit interviews in each of six public-sector family planning clinics. All clinics had at least two contraceptive methods continuously available for the preceding 6 months. Most providers asked clients about concerns with their contraceptive method (80%) and told clients when to return to the clinic (87%). Most clients reported that the provider advised what to do if a problem develops (93%), described possible side effects (89%), explained how to use the method effectively (85%) and told them when to come for follow-up (83%). Clients were satisfied with services received (93%). This application of the Quick Investigation of Quality showed that the participating family planning clinics in Lusaka, Zambia, were prepared to offer high-quality services with the available commodities and that clients were satisfied with the received services. Despite the subjective client satisfaction, quality improvement efforts are needed to increase contraceptive availability. Although clients perceived the quality of care received to be high, family planning service quality could be improved to continuously offer the full spectrum of contraceptive options. The Quick Investigation of Quality was easily implemented in Lusaka, Zambia, and this simple approach could be utilized in a variety of settings as a modality for quality improvement. Copyright © 2015

  1. Validation of a clinical leadership qualities framework for managers in aged care: a Delphi study.

    Science.gov (United States)

    Jeon, Yun-Hee; Conway, Jane; Chenoweth, Lynn; Weise, Janelle; Thomas, Tamsin Ht; Williams, Anna

    2015-04-01

    To establish validity of a clinical leadership framework for aged care middle managers (The Aged care Clinical Leadership Qualities Framework). Middle managers in aged care have responsibility not only for organisational governance also and operational management but also quality service delivery. There is a need to better define clinical leadership abilities in aged care middle managers, in order to optimise their positional authority to lead others to achieve quality outcomes. A Delphi method. Sixty-nine experts in aged care were recruited, representing rural, remote and metropolitan community and residential aged care settings. Panellists were asked to rate the proposed framework in terms of the relevance and importance of each leadership quality using four-point Likert scales, and to provide comments. Three rounds of consultation were conducted. The number and corresponding percentage of the relevance and importance rating for each quality was calculated for each consultation round, as well as mean scores. Consensus was determined to be reached when a percentage score reached 70% or greater. Twenty-three panellists completed all three rounds of consultation. Following the three rounds of consultation, the acceptability and face validity of the framework was confirmed. The study confirmed the framework as useful in identifying leadership requirements for middle managers in Australian aged care settings. The framework is the first validated framework of clinical leadership attributes for middle managers in aged care and offers an initial step forward in clarifying the aged care middle manager role. The framework provides clarity in the breadth of role expectations for the middle managers and can be used to inform an aged care specific leadership program development, individuals' and organisations' performance and development processes; and policy and guidelines about the types of activities required of middle managers in aged care. © 2014 John Wiley & Sons Ltd.

  2. Clinical relevance is associated with allergen-specific wheal size in skin prick testing

    DEFF Research Database (Denmark)

    Haahtela, T.; Burbach, G. J.; Bachert, C.

    2014-01-01

    , asthma, atopic dermatitis, food allergy). The effects of age, gender, and geographical area on SPT results were assessed. For each allergen, the wheal size in mm with an 80% positive predictive value (PPV) for being clinically relevant was calculated. ResultsDepending on the allergen, from 40% (blatella...... by providing quantitative decision points. MethodsThe GA(2)LEN SPT study with 3068 valid data sets was used to investigate the relationship between SPT results and patient-reported clinical relevance for each of the 18 inhalant allergens as well as SPT wheal size and physician-diagnosed allergy (rhinitis...... SPT reactions had a smaller risk of sensitizations being clinically relevant compared with adults. The 80% PPV varied from 3 to 10mm depending on the allergen. ConclusionThese reading keys' for 18 inhalant allergens can help interpret SPT results with respect to their clinical significance. A SPT form...

  3. Development of clinically relevant implantable pressure sensors: perspectives and challenges.

    Science.gov (United States)

    Clausen, Ingelin; Glott, Thomas

    2014-09-22

    This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians.  Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.

  4. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.

    Science.gov (United States)

    Driver, Vickie R; Gould, Lisa J; Dotson, Peggy; Gibbons, Gary W; Li, William W; Ennis, William J; Kirsner, Robert S; Eaglstein, William H; Bolton, Laura L; Carter, Marissa J

    2017-05-01

    Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory

  5. Improving the quality of clinical coding: a comprehensive audit model

    Directory of Open Access Journals (Sweden)

    Hamid Moghaddasi

    2014-04-01

    Full Text Available Introduction: The review of medical records with the aim of assessing the quality of codes has long been conducted in different countries. Auditing medical coding, as an instructive approach, could help to review the quality of codes objectively using defined attributes, and this in turn would lead to improvement of the quality of codes. Method: The current study aimed to present a model for auditing the quality of clinical codes. The audit model was formed after reviewing other audit models, considering their strengths and weaknesses. A clear definition was presented for each quality attribute and more detailed criteria were then set for assessing the quality of codes. Results: The audit tool (based on the quality attributes included legibility, relevancy, completeness, accuracy, definition and timeliness; led to development of an audit model for assessing the quality of medical coding. Delphi technique was then used to reassure the validity of the model. Conclusion: The inclusive audit model designed could provide a reliable and valid basis for assessing the quality of codes considering more quality attributes and their clear definition. The inter-observer check suggested in the method of auditing is of particular importance to reassure the reliability of coding.

  6. Clinical image quality evaluation for panoramic radiography in Korean dental clinics

    International Nuclear Information System (INIS)

    Choi, Bo Ram; Choi, Da Hye; Huh, Kyung Hoe; Yi, Won Jin; Heo, Min Suk; Choi, Soon Chul; Bae, Kwang Hak; Lee, Sam Sun

    2012-01-01

    The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively.

  7. Quality of clinical trials: A moving target

    Science.gov (United States)

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  8. Quality Primary Care and Family Planning Services for LGBT Clients: A Comprehensive Review of Clinical Guidelines.

    Science.gov (United States)

    Klein, David A; Malcolm, Nikita M; Berry-Bibee, Erin N; Paradise, Scott L; Coulter, Jessica S; Keglovitz Baker, Kristin; Schvey, Natasha A; Rollison, Julia M; Frederiksen, Brittni N

    2018-04-01

    LGBT clients have unique healthcare needs but experience a wide range of quality in the care that they receive. This study provides a summary of clinical guideline recommendations related to the provision of primary care and family planning services for LGBT clients. In addition, we identify gaps in current guidelines, and inform future recommendations and guidance for clinical practice and research. PubMed, Cochrane, and Agency for Healthcare Research and Quality electronic bibliographic databases, and relevant professional organizations' websites, were searched to identify clinical guidelines related to the provision of primary care and family planning services for LGBT clients. Information obtained from a technical expert panel was used to inform the review. Clinical guidelines meeting the inclusion criteria were assessed to determine their alignment with Institute of Medicine (IOM) standards for the development of clinical practice guidelines and content relevant to the identified themes. The search parameters identified 2,006 clinical practice guidelines. Seventeen clinical guidelines met the inclusion criteria. Two of the guidelines met all eight IOM criteria. However, many recommendations were consistent regarding provision of services to LGBT clients within the following themes: clinic environment, provider cultural sensitivity and awareness, communication, confidentiality, coordination of care, general clinical principles, mental health considerations, and reproductive health. Guidelines for the primary and family planning care of LGBT clients are evolving. The themes identified in this review may guide professional organizations during guideline development, clinicians when providing care, and researchers conducting LGBT-related studies.

  9. Psychometric properties and clinical relevance of the adolescent sleep hygiene scale in Dutch adolescents.

    Science.gov (United States)

    de Bruin, Eduard J; van Kampen, Ris K A; van Kooten, Tamar; Meijer, Anne Marie

    2014-07-01

    This study investigated reliability, validity, and clinical relevance of the Adolescent Sleep Hygiene Scale (ASHS) in Dutch adolescents. The Dutch translation of the ASHS was administered to 186 normal-sleeping adolescents and 112 adolescents with insomnia. Their sleep variables were measured using sleep logs and questionnaires. From the insomnia group, scores were also obtained after six weeks of cognitive behavioral therapy for insomnia (n=58) or waiting list (n=22). The full scale of the ASHS had acceptable internal consistency. The results showed moderate to strong correlations of the ASHS (domains) with sleep quality, sleep duration and chronic sleep reduction. Furthermore, the Dutch ASHS was able to discriminate between normal sleepers and adolescents with insomnia, and scores of adolescents with insomnia improved after treatment. These findings confirm the importance of sleep hygiene in adolescent sleep, and contribute to the validity of the ASHS and its applicability in research and clinical practice. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. Measuring agreement between rating interpretations and binary clinical interpretations of images: a simulation study of methods for quantifying the clinical relevance of an observer performance paradigm

    International Nuclear Information System (INIS)

    Chakraborty, Dev P

    2012-01-01

    Laboratory receiver operating characteristic (ROC) studies, that are often used to evaluate medical imaging systems, differ from ‘live’ clinical interpretations in several respects which could compromise their clinical relevance. The aim was to develop methodology for quantifying the clinical relevance of a laboratory ROC study. A simulator was developed to generate ROC ratings data and binary clinical interpretations classified as correct or incorrect for a common set of images interpreted under clinical and laboratory conditions. The area under the trapezoidal ROC curve (AUC) was used as the laboratory figure-of-merit and the fraction of correct clinical decisions as the clinical figure-of-merit. Conventional agreement measures (Pearson, Spearman, Kendall and kappa) between the bootstrap-induced fluctuations of the two figures of merit were estimated. A jackknife pseudovalue transformation applied to the figures of merit was also investigated as a way to capture agreement existing at the individual image level that could be lost at the figure-of-merit level. It is shown that the pseudovalues define a relevance-ROC curve. The area under this curve (rAUC) measures the ability of the laboratory figure-of-merit-based pseudovalues to correctly classify incorrect versus correct clinical interpretations. Therefore, rAUC is a measure of the clinical relevance of an ROC study. The conventional measures and rAUC were compared under varying simulator conditions. It was found that design details of the ROC study, namely the number of bins, the difficulty level of the images, the ratio of disease-present to disease-absent images and the unavoidable difference between laboratory and clinical performance levels, can lead to serious underestimation of the agreement as indicated by conventional agreement measures, even for perfectly correlated data, while rAUC showed high agreement and was relatively immune to these details. At the same time rAUC was sensitive to factors such

  11. GA(2)LEN skin test study II: clinical relevance of inhalant allergen sensitizations in Europe

    DEFF Research Database (Denmark)

    Burbach, G J; Heinzerling, L M; Edenharter, G

    2009-01-01

    BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance was ...... the clinical relevance of positive skin prick tests and calls for further studies, which may, ultimately, help increase the positive predictive value of allergy testing.......BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance...... was used to determine the clinical relevance of sensitizations against the 18 most frequent inhalant allergens in Europe. The study population consisted of patients referred to one of the 17 allergy centres in 14 European countries (n = 3034, median age = 33 years). The aim of the study was to assess...

  12. Quality assurance of asthma clinical trials.

    Science.gov (United States)

    Malmstrom, Kerstin; Peszek, Iza; Al Botto; Lu, Susan; Enright, Paul L; Reiss, Theodore F

    2002-04-01

    Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.

  13. Depression as a Clinical Determinant of Dependence and Low Quality of Life in Elderly Patients with Cardiovascular Disease

    Directory of Open Access Journals (Sweden)

    Giselle Helena de Paula Rodrigues

    2015-06-01

    Full Text Available Background: The aging process promotes a progressive increase in chronic-degenerative diseases. The effect of these diseases on the functional capacity has been well recognized. Another health parameter concerns “quality of life related to health”. Among the elderly population, cardiovascular diseases stand out due to the epidemiological and clinical impact. Usually, these diseases have been associated with others. This set of problems may compromise both independence and quality of life in elderly patients who seek cardiologic treatment. These health parameters have not been well contemplated by cardiologists. Objective: Evaluating, among the elderly population with cardiovascular disease, which are the most relevant clinical determinants regarding dependence and quality of life. Methods: This group was randomly and consecutively selected and four questionnaires were applied: HAQ, SF-36, PRIME-MD e Mini Mental State. Results: The study included 1,020 elderly patients, 63.3% women. The group had been between 60 and 97 years-old (mean: 75.56 ± 6.62 years-old. 61.4% were independent or mild dependence. The quality of life total score was high (HAQ: 88.66 ± 2.68. 87.8% of patients had a SF-36 total score > 66. In the multivariate analysis, the association between diagnoses and high degrees of dependence was significant only for previous stroke (p = 0.014, obesity (p < 0.001, lack of physical activity (p = 0.016, osteoarthritis (p < 0.001, cognitive impairment (p < 0.001, and major depression (p < 0.001. Analyzing the quality of life, major depression and physical illness for depression was significantly associated with all domains of the SF-36. Conclusion: Among an elderly outpatient cardiology population, dependence and quality of life clinical determinants are not cardiovascular comorbidities, especially the depression.

  14. Clinical image quality evaluation for panoramic radiography in Korean dental clinics

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Bo Ram; Choi, Da Hye; Huh, Kyung Hoe; Yi, Won Jin; Heo, Min Suk; Choi, Soon Chul; Bae, Kwang Hak; Lee, Sam Sun [School of Dentistry, Seoul National University, Seoul (Korea, Republic of)

    2012-09-15

    The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively.

  15. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  16. Molecular Characterization and Clinical Relevance of Metabolic Expression Subtypes in Human Cancers

    Directory of Open Access Journals (Sweden)

    Xinxin Peng

    2018-04-01

    Full Text Available Summary: Metabolic reprogramming provides critical information for clinical oncology. Using molecular data of 9,125 patient samples from The Cancer Genome Atlas, we identified tumor subtypes in 33 cancer types based on mRNA expression patterns of seven major metabolic processes and assessed their clinical relevance. Our metabolic expression subtypes correlated extensively with clinical outcome: subtypes with upregulated carbohydrate, nucleotide, and vitamin/cofactor metabolism most consistently correlated with worse prognosis, whereas subtypes with upregulated lipid metabolism showed the opposite. Metabolic subtypes correlated with diverse somatic drivers but exhibited effects convergent on cancer hallmark pathways and were modulated by highly recurrent master regulators across cancer types. As a proof-of-concept example, we demonstrated that knockdown of SNAI1 or RUNX1—master regulators of carbohydrate metabolic subtypes—modulates metabolic activity and drug sensitivity. Our study provides a system-level view of metabolic heterogeneity within and across cancer types and identifies pathway cross-talk, suggesting related prognostic, therapeutic, and predictive utility. : Peng et al. analyze a cohort of 9,125 TCGA samples across 33 cancer types to characterize tumor subtypes based on the expression of seven metabolic pathways. They find metabolic expression subtypes are associated with patient survivals and suggest the therapeutic and predictive relevance of subtype-related master regulators. Keywords: The Cancer Genome Atlas, tumor subtypes, prognostic markers, somatic drivers, master regulator, therapeutic targets, drug sensitivity, carbohydrate metabolism

  17. Intraductal papillary mucinous neoplasms of the pancreas: reporting clinically relevant features.

    Science.gov (United States)

    Del Chiaro, Marco; Verbeke, Caroline

    2017-05-01

    Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas can exhibit a wide spectrum of macroscopic and microscopic appearances. This not only causes occasional difficulties for the reporting pathologist in distinguishing these tumours from other lesions, but is also relevant clinically. As evidence accumulates, it becomes clear that multiple macroscopic and histological features of these neoplasms are relevant to the risk for malignant transformation and, consequently, of prime importance for clinical patient management. The need for detailed reporting is therefore increasing. This review discusses the panoply of gross and microscopic features of IPMN as well as the recommendations from recent consensus meetings regarding the pathology reporting on this tumour entity. © 2016 John Wiley & Sons Ltd.

  18. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  19. High rates of clinically relevant incidental findings by total-body CT scanning in trauma patients; results of the REACT-2 trial

    Energy Technology Data Exchange (ETDEWEB)

    Treskes, K.; Bos, S.A.; Sierink, J.C.; Luitse, J.S.K.; Goslings, J.C. [Academic Medical Center, Trauma Unit, Department of Surgery, Amsterdam (Netherlands); Beenen, L.F.M. [Academic Medical Center, Department of Radiology, Amsterdam (Netherlands); Edwards, M.J.R. [Radboud University Medical Center, Department of Trauma and emergency surgery, Nijmegen (Netherlands); Beuker, B.J.A. [University Medical Center Groningen, Trauma Unit, Department of Surgery, Groningen (Netherlands); Muradin, G.S.R. [University Medical Center Rotterdam, Department of Radiology, Erasmus MC, Rotterdam (Netherlands); Hohmann, J. [University of Basel Hospital, Department of Radiology and Nuclear Medicine, Basel (Switzerland); Hollmann, M.W. [Academic Medical Center, Department of Anaesthesiology, Amsterdam (Netherlands); Dijkgraaf, M.G.W. [Academic Medical Center, Clinical Research Unit, Amsterdam (Netherlands); Collaboration: REACT-2 study group

    2017-06-15

    To determine whether there is a difference in frequency and clinical relevance of incidental findings detected by total-body computed tomography scanning (TBCT) compared to those by the standard work-up (STWU) with selective computed tomography (CT) scanning. Trauma patients from five trauma centres were randomized between April 2011 and January 2014 to TBCT imaging or STWU consisting of conventional imaging with selective CT scanning. Incidental findings were divided into three categories: 1) major finding, may cause mortality; 2) moderate finding, may cause morbidity; and 3) minor finding, hardly relevant. Generalized estimating equations were applied to assess differences in incidental findings. In total, 1083 patients were enrolled, of which 541 patients (49.9 %) were randomized for TBCT and 542 patients (50.1 %) for STWU. Major findings were detected in 23 patients (4.3 %) in the TBCT group compared to 9 patients (1.7 %) in the STWU group (adjusted rate ratio 2.851; 95%CI 1.337-6.077; p < 0.007). Findings of moderate relevance were detected in 120 patients (22.2 %) in the TBCT group compared to 86 patients (15.9 %) in the STWU group (adjusted rate ratio 1.421; 95%CI 1.088-1.854; p < 0.010). Compared to selective CT scanning, more patients with clinically relevant incidental findings can be expected by TBCT scanning. (orig.)

  20. Whole-Exome Sequencing Reveals Clinically Relevant Variants in Family Affected with Autism Spectrum Disorder

    Directory of Open Access Journals (Sweden)

    Jiaxiu Zhou

    2016-10-01

    Full Text Available Chromosomal microarray (CMA has been suggested as a first tier clinical diagnostic test for ASD. High-throughput sequencing (HTS has associated hundreds of genes associated with ASD. Whole Exome Sequencing (WES was used in combination with CMA to identify clinically-relevant ASD variants. In prior work, a trio-based (father, mother, and proband WGS (Whole Genome Sequencing was used to reveal clinically-relevant de novo, or inherited, rare variants in half (16 / 32 of the ASD families in which all probands had normal, or VOUS (Variant of Uncertain Clinical Significance, CMA results. In this study, after CMA screening chromosome structural abnormalities of a proband affected with ASD, a WES was performed on the patient and parents. Some rare de novo, and inherited, variants were detected using trio-based bioinformatics analysis. ASD variants were ranked by SFARI Gene score, HPO (human phenotype ontology, protein function damage, and manual searching PubMed. Sanger sequencing was used to validated some candidate variants in family members. A de novo homozygous mutation in SPG11 (p.C209F, two inherited, compound-heterozygote mutations in SCN9A (p.Q10R and p.R1893H and BEST1 (p.A135V and p.A297V were confirmed. Heterozygous mutations in TSC1 (p.S487C and SHANK2 (p.Arg569His inherited from mother were also confirmed.

  1. The Quality of Life and relevant Approaches based on Capabilities and Functionalities

    Directory of Open Access Journals (Sweden)

    Matei Șimandan

    2014-12-01

    Full Text Available Recent research regarding the quality of life developed different approaches concerning the use of objective and subjective indicators, as well as the relevance of hypotheses, propositions and methods of analysis or of evaluation. Starting from the conceptual difficulties regarding the term of ‘quality of life’, this article focuses upon the contributions of Amartya Sen on the relationships between resources, liberties, capabilities, functionalities and human development. A separate section attempts to capture the shift of accent from the approaches of a quantitative type towards those of a qualitative type, founded on capabilities, functionalities, and the factors of conversion of resources into elements of quality of subjective life. The following sections are consecrated to the contributions to the development of the model proposed by Amartya Sen and to the reception of this model by a few specialists in the field, as well as to its relevance within scientific research and the foundation of public policies.

  2. Out of sight, out of mind: why doesn't widespread clinical quality failure command our attention?

    Science.gov (United States)

    Milstein, Arnold; Adler, Nancy E

    2003-01-01

    This paper examines the tolerance by all stakeholders of increasingly well documented evidence of serious and widespread clinical quality failure in the United States. Using research evidence from psychology, it describes specific cognitive and motivational impediments to the perception of quality failure-those shared by all stakeholders and those particularly relevant to patients and their families and to health care professionals. The authors endorse efforts by the National Quality Forum and others to make quality failure more publicly visible. They also point to the pivotal role of health care industry leaders in sustaining focus on a problem that inherently resists visibility.

  3. Do Clinical Practice Guidelines Improve Quality?

    Science.gov (United States)

    Baldassari, Cristina M

    2017-07-01

    Controversy exists surrounding how to best define and assess quality in the health care setting. Clinical practice guidelines (CPGs) have been developed to improve the quality of medical care by highlighting key clinical recommendations based on recent evidence. However, data linking CPGs to improvements in outcomes in otolaryngology are lacking. Numerous barriers contribute to difficulties in translating CPGs to improvements in quality. Future initiatives are needed to improve CPG adherence and define the impact of CPG recommendations on the quality of otolaryngologic care provided to our patients.

  4. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice

    DEFF Research Database (Denmark)

    Sturgeon, Catharine M; Hoffman, Barry R; Chan, Daniel W

    2008-01-01

    BACKGROUND: This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS: One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor...... questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence...... records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical...

  5. Improved clinical status, quality of life, and walking capacity in Parkinson's disease after body weight-supported high-intensity locomotor training

    DEFF Research Database (Denmark)

    Rose, Martin Høyer; Løkkegaard, Annemette; Sonne-Holm, Stig

    2013-01-01

    OBJECTIVE: To evaluate the effect of body weight-supported progressive high-intensity locomotor training in Parkinson's disease (PD) on (1) clinical status; (2) quality of life; and (3) gait capacity. DESIGN: Open-label, fixed sequence crossover study. SETTING: University motor control laboratory......±93 to 637±90m. CONCLUSIONS: Body weight-supported progressive high-intensity locomotor training is feasible and well tolerated by patients with PD. The training improved clinical status, quality of life, and gait capacity significantly....... were found in all outcome measures compared with the control period. Total MDS-UPDRS score changed from (mean ± 1SD) 58±18 to 47±18, MDS-UPDRS motor part score changed from 35±10 to 29±12, PDQ-39 summary index score changed from 22±13 to 13±12, and the six-minute walking distance changed from 576...

  6. Clinical Relevance of Nontuberculous Mycobacteria Isolated from Sputum in a Gold Mining Workforce in South Africa: An Observational, Clinical Study

    Directory of Open Access Journals (Sweden)

    Clare L. van Halsema

    2015-01-01

    Full Text Available Background. The clinical relevance of nontuberculous mycobacteria (NTM, detected by liquid more than solid culture in sputum specimens from a South African mining workforce, is uncertain. We aimed to describe the current spectrum and relevance of NTM in this population. Methods. An observational study including individuals with sputum NTM isolates, recruited at workforce tuberculosis screening and routine clinics. Symptom questionnaires were administered at the time of sputum collection and clinical records and chest radiographs reviewed retrospectively. Results. Of 232 individuals included (228 (98% male, median age 44 years, M. gordonae (60 individuals, M. kansasii (50, and M. avium complex (MAC: 38 were the commonest species. Of 38 MAC isolates, only 2 (5.3% were from smear-positive sputum specimens and 30/38 grew in liquid but not solid culture. MAC was especially prevalent among symptomatic, HIV-positive individuals. HIV prevalence was high: 57/74 (77% among those tested. No differences were found in probability of death or medical separation by NTM species. Conclusions. M. gordonae, M. kansasii, and MAC were the commonest NTM among miners with suspected tuberculosis, with most MAC from smear-negative specimens in liquid culture only. HIV testing and identification of key pathogenic NTM in this setting are essential to ensure optimal treatment.

  7. Clinical relevance of the gap between pre-marketing trials and medical practice : the case of the cardiovascular drugs

    NARCIS (Netherlands)

    Wieringa, N F; Denig, P; de Graeff, P A; Vos, R

    OBJECTIVES/BACKGROUND: The external validity of trial results of new cardiovascular drugs is limited, because the short-term studies are performed with relatively small, highly selected populations. Using qualitative methods, we examined the clinical relevance of under-representation of subgroups of

  8. Decaying relevance of clinical data towards future decisions in data-driven inpatient clinical order sets.

    Science.gov (United States)

    Chen, Jonathan H; Alagappan, Muthuraman; Goldstein, Mary K; Asch, Steven M; Altman, Russ B

    2017-06-01

    Determine how varying longitudinal historical training data can impact prediction of future clinical decisions. Estimate the "decay rate" of clinical data source relevance. We trained a clinical order recommender system, analogous to Netflix or Amazon's "Customers who bought A also bought B..." product recommenders, based on a tertiary academic hospital's structured electronic health record data. We used this system to predict future (2013) admission orders based on different subsets of historical training data (2009 through 2012), relative to existing human-authored order sets. Predicting future (2013) inpatient orders is more accurate with models trained on just one month of recent (2012) data than with 12 months of older (2009) data (ROC AUC 0.91 vs. 0.88, precision 27% vs. 22%, recall 52% vs. 43%, all P<10 -10 ). Algorithmically learned models from even the older (2009) data was still more effective than existing human-authored order sets (ROC AUC 0.81, precision 16% recall 35%). Training with more longitudinal data (2009-2012) was no better than using only the most recent (2012) data, unless applying a decaying weighting scheme with a "half-life" of data relevance about 4 months. Clinical practice patterns (automatically) learned from electronic health record data can vary substantially across years. Gold standards for clinical decision support are elusive moving targets, reinforcing the need for automated methods that can adapt to evolving information. Prioritizing small amounts of recent data is more effective than using larger amounts of older data towards future clinical predictions. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  9. External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China.

    Science.gov (United States)

    Wang, Lu-nan; Zhang, Rui; Shen, Zi-yu; Chen, Wen-xiang; Li, Jin-ming

    2008-06-05

    As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China (NCCL). The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus (HCV) RNA. Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value (TG) designated as +/- 0.5 log. The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens (10(3) IU/ml). The percentage of results within the range of GM +/- 0.5 log(10) varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest (3.00 log IU/ml) as well as of the highest viral levels (6.37 log IU/ml) values, very near to the limits of the dynamic range of the assays. The comparison of these results with the previous study confirms that a regular participation in external quality assessment (EQA) assures the achievement of a high

  10. Relevant Subspace Clustering

    DEFF Research Database (Denmark)

    Müller, Emmanuel; Assent, Ira; Günnemann, Stephan

    2009-01-01

    Subspace clustering aims at detecting clusters in any subspace projection of a high dimensional space. As the number of possible subspace projections is exponential in the number of dimensions, the result is often tremendously large. Recent approaches fail to reduce results to relevant subspace...... clusters. Their results are typically highly redundant, i.e. many clusters are detected multiple times in several projections. In this work, we propose a novel model for relevant subspace clustering (RESCU). We present a global optimization which detects the most interesting non-redundant subspace clusters...... achieves top clustering quality while competing approaches show greatly varying performance....

  11. Relevance of human anatomy in daily clinical practice.

    Science.gov (United States)

    Arráez-Aybar, Luis-Alfonso; Sánchez-Montesinos, Indalecio; Mirapeix, Rosa-M; Mompeo-Corredera, Blanca; Sañudo-Tejero, Jose-Ramón

    2010-12-20

    the aim of this study has been to evaluate the relevance of gross human anatomy in daily clinical practice and to compare it to that of other basic sciences (biochemistry, bioethics, cytohistology, microbiology, pharmacology, physiology, psychology). a total of 1250 questionnaires were distributed among 38 different medical speciality professionals. Answers were analyzed taking into account speciality (medical, surgery and others), professional status (training physician or staff member) and professional experience. the response rate was 42.9% (n=536). Gross human anatomy was considered the most relevant basic discipline for surgical specialists, while pharmacology and physiology were most relevant for medical specialists. Knowledge of anatomy was also considered fundamental for understanding neurological or musculoskeletal disorders. In undergraduate programmes, the most important focuses in teaching anatomy were radiological, topographical and functional anatomy followed by systematic anatomy. In daily medical practice anatomy was considered basic for physical examination, symptom interpretation and interpretation of radiological images. When professional status or professional experience was considered, small variations were shown and there were no significant differences related to gender or community. our results underline the relevance of basic sciences (gross anatomy, physiology, and pharmacology) in daily professional activity. Evidence-based studies such as ours, lend greater credibility and objectivity to the role of gross anatomy in the undergraduate training of health professionals and should help to establish a more appropriate curriculum for future professionals. 2010 Elsevier GmbH. All rights reserved.

  12. Relevant aspects of a quality assurance program applied to a nuclear power plant operation

    International Nuclear Information System (INIS)

    Fernandez, J.C.

    1987-01-01

    The purpose of this work was to enumerate the most relevant subjects to be taken into account for the elaboration of a Quality Assurance Program aimed to regulate a nuclear power plant operation. At first, it was necessary to point out the relevance that implies the presence of a group of personnel, experienced in quality assurance with enough knowledge on the technical and organizing aspects of the plant. Other aspect to be taken into account was the contemplation of the international requirements, through the International Atomic Energy Agency and of the national requirements that each country had set up by the corresponding regulating agencies. These organizations pointed out the minimum rules that must be followed for the adequate and efficient execution of a program. The Quality Assurance Manual and the program and work procedures constituted the Quality Assurance Program which must be checked as regards its fulfillment by auditors and quality assurance supervisions. (Author)

  13. Correlation of bone quality in radiographic images with clinical bone quality classification

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyun Woo; Huh, Kyung Hoe; Kim, Jeong Hwa; Yi, Won Jin; Heo, Min Suk; Lee, Sam Sun; Choi, Soon Chul [Seoul National University, Seoul (Korea, Republic of); Park, Kwan Soo [Inje University, Seoul (Korea, Republic of)

    2006-03-15

    To investigate the validity of digital image processing on panoramic radiographs in estimating bone quality before endosseous dental implant installation by correlating bone quality in radiographic images with clinical bone quality classification. An experienced surgeon assessed and classified bone quality for implant sites with tactile sensation at the time of implant placement. Including fractal dimension eighteen morphologic features of trabecular pattern were examined in each anatomical sites on panoramic radiographs. Finally bone quality of 67 implant sites were evaluated in 42 patients. Pearson correlation analysis showed that three morphologic parameters had weak linear negative correlation with clinical bone quality classification showing correlation coefficients of -0.276, -0.280, and -0.289, respectively (p<0.05). And other three morphologic parameters had obvious linear negative correlation with clinical bone quality classification showing correlation coefficients of -0.346, -0.488, and -0.343 respectively (p<0.05). Fractal dimension also had a linear correlating with clinical bone quality classification with correlation coefficients -0.506 significantly (P<0.05). This study suggests that fractal and morphometric analysis using digital panoramic radiographs can be used to evaluate bone quality for implant recipient sites.

  14. Development and clinical translation of a cone-beam CT scanner for high-quality imaging of intracranial hemorrhage

    Science.gov (United States)

    Sisniega, A.; Xu, J.; Dang, H.; Zbijewski, W.; Stayman, J. W.; Mow, M.; Koliatsos, V. E.; Aygun, N.; Wang, X.; Foos, D. H.; Siewerdsen, J. H.

    2017-03-01

    Purpose: Prompt, reliable detection of intracranial hemorrhage (ICH) is essential for treatment of stroke and traumatic brain injury, and would benefit from availability of imaging directly at the point-of-care. This work reports the performance evaluation of a clinical prototype of a cone-beam CT (CBCT) system for ICH imaging and introduces novel algorithms for model-based reconstruction with compensation for data truncation and patient motion. Methods: The tradeoffs in dose and image quality were investigated as a function of analytical (FBP) and model-based iterative reconstruction (PWLS) algorithm parameters using phantoms with ICH-mimicking inserts. Image quality in clinical applications was evaluated in a human cadaver imaged with simulated ICH. Objects outside of the field of view (FOV), such as the head-holder, were found to introduce challenging truncation artifacts in PWLS that were mitigated with a novel multi-resolution reconstruction strategy. Following phantom and cadaver studies, the scanner was translated to a clinical pilot study. Initial clinical experience indicates the presence of motion in some patient scans, and an image-based motion estimation method that does not require fiducial tracking or prior patient information was implemented and evaluated. Results: The weighted CTDI for a nominal scan technique was 22.8 mGy. The high-resolution FBP reconstruction protocol achieved < 0.9 mm full width at half maximum (FWHM) of the point spread function (PSF). The PWLS soft-tissue reconstruction showed <1.2 mm PSF FWHM and lower noise than FBP at the same resolution. Effects of truncation in PWLS were mitigated with the multi-resolution approach, resulting in 60% reduction in root mean squared error compared to conventional PWLS. Cadaver images showed clear visualization of anatomical landmarks (ventricles and sulci), and ICH was conspicuous. The motion compensation method was shown in clinical studies to restore visibility of fine bone structures

  15. Exploring Issues of Relevance and Quality in the Context of a ...

    African Journals Online (AJOL)

    This paper draws insights from a mini research project that was conducted at the University of Botswana in Botswana, within a wider, collaborative research effort established amongst five universities in the Southern African Development Community which focused on the links between educational quality and relevance and ...

  16. Laboratory exercises to teach clinically relevant chemistry of antibiotics.

    Science.gov (United States)

    El Sayed, Khalid A; Chelette, Candace T

    2014-03-12

    To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with laboratory exercises. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students' performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises.

  17. Outcome quality of in-patient cardiac rehabilitation in elderly patients--identification of relevant parameters.

    Science.gov (United States)

    Salzwedel, Annett; Nosper, Manfred; Röhrig, Bernd; Linck-Eleftheriadis, Sigrid; Strandt, Gert; Völler, Heinz

    2014-02-01

    Outcome quality management requires the consecutive registration of defined variables. The aim was to identify relevant parameters in order to objectively assess the in-patient rehabilitation outcome. From February 2009 to June 2010 1253 patients (70.9 ± 7.0 years, 78.1% men) at 12 rehabilitation clinics were enrolled. Items concerning sociodemographic data, the impairment group (surgery, conservative/interventional treatment), cardiovascular risk factors, structural and functional parameters and subjective health were tested in respect of their measurability, sensitivity to change and their propensity to be influenced by rehabilitation. The majority of patients (61.1%) were referred for rehabilitation after cardiac surgery, 38.9% after conservative or interventional treatment for an acute coronary syndrome. Functionally relevant comorbidities were seen in 49.2% (diabetes mellitus, stroke, peripheral artery disease, chronic obstructive lung disease). In three key areas 13 parameters were identified as being sensitive to change and subject to modification by rehabilitation: cardiovascular risk factors (blood pressure, low-density lipoprotein cholesterol, triglycerides), exercise capacity (resting heart rate, maximal exercise capacity, maximal walking distance, heart failure, angina pectoris) and subjective health (IRES-24 (indicators of rehabilitation status): pain, somatic health, psychological well-being and depression as well as anxiety on the Hospital Anxiety and Depression Scale). The outcome of in-patient rehabilitation in elderly patients can be comprehensively assessed by the identification of appropriate key areas, that is, cardiovascular risk factors, exercise capacity and subjective health. This may well serve as a benchmark for internal and external quality management.

  18. Clinical Relevance of Discourse Characteristics after Right Hemisphere Brain Damage

    Science.gov (United States)

    Blake, Margaret Lehman

    2006-01-01

    Purpose: Discourse characteristics of adults with right hemisphere brain damage are similar to those reported for healthy older adults, prompting the question of whether changes are due to neurological lesions or normal aging processes. The clinical relevance of potential differences across groups was examined through ratings by speech-language…

  19. Teledermatology: quality assessment by user satisfaction and clinical efficiency.

    Science.gov (United States)

    Klaz, Itay; Wohl, Yonit; Nathansohn, Nir; Yerushalmi, Nir; Sharvit, Sharon; Kochba, Ilan; Brenner, Sarah

    2005-08-01

    The Israel Defense Forces implemented a pilot teledermatology service in primary clinics. To assess user satisfaction and clinical short-term effectiveness of a computerized store and forward teledermatology service in urban and rural units. A multi-center prospective uncontrolled cohort pilot trial was conducted for a period of 6 months. Primary care physicians referred patients to a board-certified dermatologist using text email accompanied by digital photographs. Diagnosis, therapy and management were sent back to the referring PCP. Patients were asked to evaluate the level of the CSAFTD service, effect of the service on accessibility to dermatologists, respect for privacy, availability of drugs, health improvement and overall satisfaction. PCPs assessed the quality of the teledermatology consultations they received, the contribution to their knowledge, and their overall satisfaction. Tele-diagnosis alone was possible for 95% (n=413) of 435 CSAFTD referrals; 22% (n=95) of referrals also required face-to-face consultation, Satisfaction with CSAFTD was high among patients in both rural and urban clinics, with significantly higher scores in rural units. Rural patients rated the level of service, accessibility and overall satisfaction higher than did urban patients. PCPs were satisfied with the quality of the service and its contribution to their knowledge. Rural physicians rated level of service and overall satisfaction higher than did urban physicians. Tele-referrals were completed more efficiently than referral for face-to-face appointments. CSAFTD provided efficient, high quality medical service to rural and urban military clinics in the IDF.

  20. Enrichment methods to detect bone marrow micrometastases in breast carcinoma patients: clinical relevance

    International Nuclear Information System (INIS)

    Choesmel, Valérie; Pierga, Jean-Yves; Nos, Claude; Vincent-Salomon, Anne; Sigal-Zafrani, Brigitte; Thiery, Jean-Paul; Blin, Nathalie

    2004-01-01

    Improving technologies for the detection and purification of bone marrow (BM) micrometastatic cells in breast cancer patients should lead to earlier prognosis of the risk of relapse and should make it possible to design more appropriate therapies. The technique used has to overcome the challenges resulting from the small number of target cells (one per million hematopoietic cells) and the heterogeneous expression of micrometastatic cell markers. In the present study, we have assessed the clinical relevance of current methods aimed at detecting rare disseminated carcinoma cells. BM aspirates from 32 carcinoma patients were screened for the presence of micrometastatic cells positive for epithelial cell adhesion molecule and positive for cytokeratins, using optimized immunodetection methods. A comparison with data obtained for 46 control BM aspirates and a correlation with the clinical status of patients were performed. We developed a sensitive and efficient immunomagnetic protocol for the enrichment of BM micrometastases. This method was used to divide 32 breast carcinoma patients into three categories according to their epithelial cell adhesion molecule status. These categories were highly correlated with the recently revised American Joint Committee on Cancer staging system for breast cancer, demonstrating the clinical relevance of this simple and reliable immunomagnetic technique. We also evaluated immunocytochemical detection of cytokeratin-positive cells and cytomorphological parameters. Immunocytochemistry-based methods for the detection of BM micrometastases did not provide any information about the clinical status of patients, but helped to refine the immunomagnetic data by confirming the presence of micrometastases in some cases. We also tested a new density gradient centrifugation system, able to enrich the tumor fraction of BM specimens by twofold to threefold as compared with standard Ficoll methods. These improved methods for the detection of

  1. There’s an App for That? Highlighting the Difficulty in Finding Clinically Relevant Smartphone Applications

    Directory of Open Access Journals (Sweden)

    Warren Wiechmann, MD, MBA

    2016-03-01

    Full Text Available Introduction: The use of personal mobile devices in the medical field has grown quickly, and a large proportion of physicians use their mobile devices as an immediate resource for clinical decisionmaking, prescription information and other medical information. The iTunes App Store (Apple, Inc. contains approximately 20,000 apps in its “Medical” category, providing a robust repository of resources for clinicians; however, this represents only 2% of the entire App Store. The App Store does not have strict criteria for identifying content specific to practicing physicians, making the identification of clinically relevant content difficult. The objective of this study is to quantify the characteristics of existing medical applications in the iTunes App Store that could be used by emergency physicians, residents, or medical students. Methods: We found applications related to emergency medicine (EM by searching the iTunes App Store for 21 terms representing core content areas of EM, such as “emergency medicine,” “critical care,” “orthopedics,” and “procedures.” Two physicians independently reviewed descriptions of these applications in the App Store and categorized each as the following: Clinically Relevant, Book/ Published Source, Non-English, Study Tools, or Not Relevant. A third physician reviewer resolved disagreements about categorization. Descriptive statistics were calculated. Results: We found a total of 7,699 apps from the 21 search terms, of which 17.8% were clinical, 9.6% were based on a book or published source, 1.6% were non-English, 0.7% were clinically relevant patient education resources, and 4.8% were study tools. Most significantly, 64.9% were considered not relevant to medical professionals. Clinically relevant apps make up approximately 6.9% of the App Store’s “Medical” Category and 0.1% of the overall App Store. Conclusion: Clinically relevant apps represent only a small percentage (6.9% of the total App

  2. Extracellular vesicles: fundamentals and clinical relevance

    Directory of Open Access Journals (Sweden)

    Wael Nassar

    2015-01-01

    Full Text Available All types of cells of eukaryotic organisms produce and release small nanovesicles into their extracellular environment. Early studies have described these vesicles as ′garbage bags′ only to remove obsolete cellular molecules. Valadi and colleagues, in 2007, were the first to discover the capability of circulating extracellular vesicles (EVs to horizontally transfer functioning gene information between cells. These extracellular vesicles express components responsible for angiogenesis promotion, stromal remodeling, chemoresistance, genetic exchange, and signaling pathway activation through growth factor/receptor transfer. EVs represent an important mode of intercellular communication by serving as vehicles for transfer between cells of membrane and cytosolic proteins, lipids, signaling proteins, and RNAs. They contribute to physiology and pathology, and they have a myriad of potential clinical applications in health and disease. Moreover, vesicles can pass the blood-brain barrier and may perhaps even be considered as naturally occurring liposomes. These cell-derived EVs not only represent a central mediator of the disease microenvironment, but their presence in the peripheral circulation may serve as a surrogate for disease biopsies, enabling real-time diagnosis and disease monitoring. In this review, we′ll be addressing the characteristics of different types of extracellular EVs, as well as their clinical relevance and potential as diagnostic markers, and also define therapeutic options.

  3. Using business intelligence to monitor clinical quality metrics.

    Science.gov (United States)

    Resetar, Ervina; Noirot, Laura A; Reichley, Richard M; Storey, Patricia; Skiles, Ann M; Traynor, Patrick; Dunagan, W Claiborne; Bailey, Thomas C

    2007-10-11

    BJC HealthCare (BJC) uses a number of industry standard indicators to monitor the quality of services provided by each of its hospitals. By establishing an enterprise data warehouse as a central repository of clinical quality information, BJC is able to monitor clinical quality performance in a timely manner and improve clinical outcomes.

  4. Cerebral activation studies by PET and fMRT, clinical relevance?

    International Nuclear Information System (INIS)

    Brandt, T.

    1997-01-01

    Cerebral activation studies by PET and fMRT will gain increasing clinical relevance for functional neuroanatomy (reading, speaking), localisation of largely unknown cortical functions (vestibular cortex), imaging of subjective complaints of functional impairments (pain, smell, memory), and documentation of neurological rehabilitation at neuronal level (regeneration, compensation, substitution, learning). (orig.) [de

  5. Leadership theory in clinical practice

    OpenAIRE

    Jie-Hui Xu

    2017-01-01

    In current clinical settings, effective clinical leadership ensures a high-quality health care system that consistently provides safe and efficient care. It is useful, then, for health care professionals to be able to identify the leadership styles and theories relevant to their nursing practice. Being adept in recognizing these styles not only enables nurses to develop their skills to become better leaders but also improves relationships with colleagues and leaders who have previously been c...

  6. Healthcare reform from the inside: A neurosurgical clinical quality program

    OpenAIRE

    Afsar-Manesh, Nasim; Martin, Neil A.

    2012-01-01

    During the past decade, the U.S. health care system has faced increasing challenges in delivering high quality of care, ensuring patient safety, providing access to care, and maintaining manageable costs. While reform progresses at a national level, health care providers have a responsibility and obligation to advance quality and safety. In 2009, the authors implemented a department-wide Clinical Quality Program. This Program comprised of an inter-disciplinary group of providers and staff wor...

  7. Evaluating the quality, clinical relevance, and resident perception of the radiation oncology in-training examination: A national survey.

    Science.gov (United States)

    Kim, Hyun; Bar Ad, Voichita; McAna, John; Dicker, Adam P

    2016-01-01

    The yearly radiation oncology in-training examination (ITE) by the American College of Radiology is a widely used, norm-referenced educational assessment, with high test reliability and psychometric performance. We distributed a national survey to evaluate the academic radiation oncology community's perception of the ITE. In June 2014, a 7-question online survey was distributed via e-mail to current radiation oncology residents, program directors, and attending physicians who had completed residency in the past 5 years or junior attendings. Survey questions were designed on a 5-point Likert scale. Sign test was performed with P ≤ .05 considered statistically different from neutral. Thirty-one program directors (33.3%), 114 junior attendings (35.4%), and 225 residents (41.2%) responded. Junior attendings and program directors reported that the ITE directly contributed to their preparation for the American Board of Radiology written certification (P = .050 and .004, respectively). Residents did not perceive the examination as an accurate assessment of relevant clinical and scientific knowledge (P ITE. Although the current examination allows limited feedback, establishing a venue for individualized feedback may allow continual and timely improvement of the ITE. Adopting a criterion-referenced examination may further increase resident investment in and utilization of this valuable learning tool. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

  8. Clinical librarian support for rapid review of clinical utility of cancer molecular biomarkers.

    Science.gov (United States)

    Geng, Yimin; Fowler, Clara S; Fulton, Stephanie

    2015-01-01

    The clinical librarian used a restricted literature searching and quality-filtering approach to provide relevant clinical evidence for the use of cancer molecular biomarkers by institutional policy makers and clinicians in the rapid review process. The librarian-provided evidence was compared with the cited references in the institutional molecular biomarker algorithm. The overall incorporation rate of the librarian-provided references into the algorithm was above 80%. This study suggests the usefulness of clinical librarian expertise for clinical practice. The searching and filtering methods for high-level evidence can be adopted by information professionals who are involved in the rapid literature review.

  9. Pilot for the Australian Breast Device Registry (ABDR): a national opt-out clinical quality registry for breast device surgery.

    Science.gov (United States)

    Hopper, Ingrid; Best, Renee L; McNeil, John J; Mulvany, Catherine M; Moore, Colin C M; Elder, Elisabeth; Pase, Marie; Cooter, Rodney D; Evans, Sue M

    2017-12-28

    To establish a pilot clinical quality registry (CQR) to monitor the quality of care and device performance for breast device surgery in Australia. All patients having breast device surgery from contributing hospitals in Australia. A literature review was performed which identified quality indicators for breast device surgery. A pilot CQR was established in 2011 to capture prospective data on breast device surgery. An interim Steering Committee and Management Committee were established to provide clinical governance, and guide quality indicator selection. The registry's minimum dataset was formulated in consultation with stakeholder groups; potential quality indicators were assessed in terms of (1) importance and relevance, (2) usability, (3) feasibility to collect and (4) scientific validity. Data collection was by a two-sided paper-based form with manual data entry. Seven sites were recruited, including one public hospital, four private hospitals and two day surgeries. Patients were recruited and opt-out consent used. The pilot breast device registry provides high-quality population-based data. It provides a model for developing a national CQR for breast devices; its minimum dataset and quality indicators reflect the opinions of the broad range of stakeholders. It is easily scalable, and has formed the basis for other international surgical groups establishing similar registries. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. Taijin kyofusho and social anxiety and their clinical relevance in indonesia and Switzerland.

    Science.gov (United States)

    Vriends, N; Pfaltz, M C; Novianti, P; Hadiyono, J

    2013-01-01

    Taijin Kyofusho Scale (TKS) is an interpersonal fear to offend others and is defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) as a culturally bound syndrome that occurs in Japan and Korea. Recently, cases with TKS have also been recognized in other cultures. The present questionnaire study investigated self-report TKS symptoms and social anxiety symptoms, and their clinical relevance in an Indonesian and Swiss sample. It also investigated whether self-construal is associated with TKS and social anxiety, and if self-construal is a mediator of the expected association between cultural background and social anxiety and TKS symptoms. 311 Indonesian and 349 Swiss university students filled out the Liebowitz Social Anxiety Scale, the Taijin Kyofusho Scale, the Self-Construal Scale, self-report social phobia DSM-IV criteria, and rated their wish for professional help to deal with social fears. TKS and social anxiety symptoms were higher in the Indonesian than the Swiss sample. TKS symptoms were associated with clinical relevance in Indonesia, whereas in Switzerland only social anxiety symptoms were associated with clinical relevance. Independent self-construal was negatively associated and interdependent self-construal was positively associated with TKS and social anxiety symptoms. Interdependent self-construal mediated the association between cultural background and these symptoms. TKS might be a clinically relevant syndrome in all individuals or cultures with an interdependent self-construal or less independent self-construal. The proposal to include the fear of offending others in the DSM-V criteria of social phobia is supported by the present findings.

  11. Taijin Kyofusho and Social Anxiety and their clinical relevance in Indonesia and Switzerland

    Directory of Open Access Journals (Sweden)

    Noortje eVriends

    2013-02-01

    Full Text Available Background: Taijin Kyofusho (TKS is an interpersonal fear to offend others and is defined by DSM-IV as a culturally bound syndrome that occurs in Japan and Korea. Recently, cases with TKS have also been recognized in other cultures. The present questionnaire study investigated self-report TKS symptoms and social anxiety symptoms, and their clinical relevance in an Indonesian and Swiss sample. It also investigated if self-construal is associated with TKS and social anxiety, and if self-construal is a mediator of the expected association between cultural background and social anxiety and TKS symptoms. Method: 311 Indonesian and 349 Swiss university students filled out the Liebowitz Social Anxiety Scale, the Taijin Kyofusho Scale, the Self-Construal Scale, self-report social phobia DSM-IV criteria, and rated their wish for professional help to deal with social fears.Results: TKS and social anxiety symptoms were higher in the Indonesian than the Swiss sample. TKS symptoms were associated with clinical relevance in Indonesia, whereas in Switzerland only social anxiety symptoms were associated with clinical relevance. Independent self-construal was negatively associated and interdependent self-construal was positively associated with TKS and social anxiety symptoms. Interdependent self-construal mediated the association between cultural background and these symptoms.Discussion: TKS might be a clinically relevant syndrome in all individuals or cultures with an interdependent self-construal or less independent self-construal. The proposal to include the fear of offending others in the DSM-V criteria of social phobia is supported by the present findings.

  12. Current use of high-resolution mass spectrometry in drug screening relevant to clinical and forensic toxicology and doping control.

    Science.gov (United States)

    Ojanperä, Ilkka; Kolmonen, Marjo; Pelander, Anna

    2012-05-01

    Clinical and forensic toxicology and doping control deal with hundreds or thousands of drugs that may cause poisoning or are abused, are illicit, or are prohibited in sports. Rapid and reliable screening for all these compounds of different chemical and pharmaceutical nature, preferably in a single analytical method, is a substantial effort for analytical toxicologists. Combined chromatography-mass spectrometry techniques with standardised reference libraries have been most commonly used for the purpose. In the last ten years, the focus has shifted from gas chromatography-mass spectrometry to liquid chromatography-mass spectrometry, because of progress in instrument technology and partly because of the polarity and low volatility of many new relevant substances. High-resolution mass spectrometry (HRMS), which enables accurate mass measurement at high resolving power, has recently evolved to the stage that is rapidly causing a shift from unit-resolution, quadrupole-dominated instrumentation. The main HRMS techniques today are time-of-flight mass spectrometry and Orbitrap Fourier-transform mass spectrometry. Both techniques enable a range of different drug-screening strategies that essentially rely on measuring a compound's or a fragment's mass with sufficiently high accuracy that its elemental composition can be determined directly. Accurate mass and isotopic pattern acts as a filter for confirming the identity of a compound or even identification of an unknown. High mass resolution is essential for improving confidence in accurate mass results in the analysis of complex biological samples. This review discusses recent applications of HRMS in analytical toxicology.

  13. Comprehensive genomic profiling of 295 cases of clinically advanced urothelial carcinoma of the urinary bladder reveals a high frequency of clinically relevant genomic alterations.

    Science.gov (United States)

    Ross, Jeffrey S; Wang, Kai; Khaira, Depinder; Ali, Siraj M; Fisher, Huge A G; Mian, Badar; Nazeer, Tipu; Elvin, Julia A; Palma, Norma; Yelensky, Roman; Lipson, Doron; Miller, Vincent A; Stephens, Philip J; Subbiah, Vivek; Pal, Sumanta K

    2016-03-01

    In the current study, the authors present a comprehensive genomic profile (CGP)-based study of advanced urothelial carcinoma (UC) designed to detect clinically relevant genomic alterations (CRGAs). DNA was extracted from 40 µm of formalin-fixed, paraffin-embedded sections from 295 consecutive cases of recurrent/metastatic UC. CGP was performed on hybridization-captured, adaptor ligation-based libraries to a mean coverage depth of 688X for all coding exons of 236 cancer-related genes plus 47 introns from 19 genes frequently rearranged in cancer, using process-matched normal control samples as a reference. CRGAs were defined as GAs linked to drugs on the market or currently under evaluation in mechanism-driven clinical trials. All 295 patients assessed were classified with high-grade (International Society of Urological Pathology classification) and advanced stage (stage III/IV American Joint Committee on Cancer) disease, and 294 of 295 patients (99.7%) had at least 1 GA on CGP with a mean of 6.4 GAs per UC (61% substitutions/insertions/deletions, 37% copy number alterations, and 2% fusions). Furthermore, 275 patients (93%) had at least 1 CRGA involving 75 individual genes with a mean of 2.6 CRGAs per UC. The most common CRGAs involved cyclin-dependent kinase inhibitor 2A (CDKN2A) (34%), fibroblast growth factor receptor 3 (FGFR3) (21%), phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) (20%), and ERBB2 (17%). FGFR3 GAs were diverse types and included 10% fusions. ERBB2 GAs were equally divided between amplifications and substitutions. ERBB2 substitutions were predominantly within the extracellular domain and were highly enriched in patients with micropapillary UC (38% of 32 cases vs 5% of 263 nonmicropapillary UC cases; PCancer 2016;122:702-711. © 2015 American Cancer Society. © 2015 American Cancer Society.

  14. Clinical relevance of the ROC and free-response paradigms for comparing imaging system efficacies

    International Nuclear Information System (INIS)

    Chakraborty, D. P.

    2010-01-01

    Observer performance studies are widely used to assess medical imaging systems. Unlike technical/engineering measurements observer performance include the entire imaging chain and the radiologist. However, the widely used receiver operating characteristic (ROC) method ignores lesion localisation information. The free-response ROC (FROC) method uses the location information to appropriately reward or penalise correct or incorrect localizations, respectively. This paper describes a method for improving the clinical relevance of FROC studies. The method consists of assigning appropriate risk values to the different lesions that may be present on a single image. A high-risk lesion is one that is critical to detect and act upon, and is assigned a higher risk value than a low-risk lesion, one that is relatively innocuous. Instead of simply counting the number of lesions that are detected, as is done in conventional FROC analysis, a risk-weighted count is used. This has the advantage of rewarding detections of high-risk lesions commensurately more than detections of lower risk lesions. Simulations were used to demonstrate that the new method, termed case-based analysis, results in a higher figure of merit for an expert who detects more high-risk lesions than a naive observer who detects more low-risk lesions, even though both detect the same total number of lesions. Conventional free-response analysis is unable to distinguish between the two types of observers. This paper also comments on the issue of clinical relevance of ROC analysis vs. FROC for tasks that involve lesion localisation. (authors)

  15. [Quality assurance and quality improvement in medical practice. Part 3: Clinical audit in medical practice].

    Science.gov (United States)

    Godény, Sándor

    2012-02-05

    The first two articles in the series were about the definition of quality in healthcare, the quality approach, the importance of quality assurance, the advantages of quality management systems and the basic concepts and necessity of evidence based medicine. In the third article the importance and basic steps of clinical audit are summarised. Clinical audit is an integral part of quality assurance and quality improvement in healthcare, that is the responsibility of any practitioner involved in medical practice. Clinical audit principally measures the clinical practice against clinical guidelines, protocols and other professional standards, and sometimes induces changes to ensure that all patients receive care according to principles of the best practice. The clinical audit can be defined also as a quality improvement process that seeks to identify areas for service improvement, develop and carry out plans and actions to improve medical activity and then by re-audit to ensure that these changes have an effect. Therefore, its aims are both to stimulate quality improvement interventions and to assess their impact in order to develop clinical effectiveness. At the end of the article key points of quality assurance and improvement in medical practice are summarised.

  16. Relevant criteria for testing the quality of turbulence models

    DEFF Research Database (Denmark)

    Frandsen, Sten Tronæs; Ejsing Jørgensen, Hans; Sørensen, J.D.

    2007-01-01

    Seeking relevant criteria for testing the quality of turbulence models, the scale of turbulence and the gust factor have been estimated from data and compared with predictions from first-order models of these two quantities. It is found that the mean of the measured length scales is approx. 10......% smaller than the IEC model, for wind turbine hub height levels. The mean is only marginally dependent on trends in time series. It is also found that the coefficient of variation of the measured length scales is about 50%. 3sec and 10sec pre-averaging of wind speed data are relevant for MW-size wind...... turbines when seeking wind characteristics that correspond to one blade and the entire rotor, respectively. For heights exceeding 50-60m the gust factor increases with wind speed. For heights larger the 60-80m, present assumptions on the value of the gust factor are significantly conservative, both for 3...

  17. Clinical leadership for high-quality care: developing future ward leaders.

    Science.gov (United States)

    Enterkin, Judith; Robb, Elizabeth; McLaren, Susan

    2013-03-01

    This paper reports upon the development, delivery and evaluation of a leadership programme for aspiring Ward Leaders in one National Health Service Trust in England. The ward sister role is fundamental to quality patient care and clinical leadership, however the role is increasingly difficult to recruit to. A lack of formal preparation and skills development for the role has been widely acknowledged. An evaluation of a programme of education for leadership. Three cohorts (n = 60) completed the programme. Semi-structured questionnaires were completed by participants (n = 36: 60%) at the conclusion of the programme. Qualitative data from questionnaires was analysed using a thematic approach. Participants reported increased political, organizational and self-awareness, increased confidence, feelings of empowerment and the ability to empower others. Opportunities for networking with peers were valued within the action learning approach. For some participants, career intentions were clarified through reflection. The majority of participants had benefited from the leadership programme and valued this development as an empowering preparation for future careers. Investment in leadership preparation for future ward sister roles is strongly recommended as part of a strategy designed to enhance quality improvement, career path development, workforce empowerment and retention. © 2012 Blackwell Publishing Ltd.

  18. FDG PET and CT in locally advanced adenocarcinomas of the distal oesophagus. Clinical relevance of a discordant PET finding

    International Nuclear Information System (INIS)

    Stahl, A.; Wieder, H.; Schwaiger, M.; Weber, W.A.; Stollfuss, J.; Ott, K.; Fink, U.

    2005-01-01

    Aim: the incidence of adenocarcinomas of the distal oesophagus (ADE) has dramatically increased in Western countries. The clinical importance of a FDG PET finding discordant with CT was determined in patients with locally advanced ADE. In addition, tumour standardized uptake values (SUV) were correlated with patient survival. Patients, methods: 40 consecutive patients were analyzed retrospectively. All patients underwent an attenuation corrected FDG PET scan (neck, chest, abdomen) and contrast enhanced helical CT of the chest and abdomen. PET and CT scans were reviewed independently and concomitantly with respect to metastases in predefined lymph node sites and organs. Any discordance between PET and CT was assessed for clinical relevance. Clinical relevance was defined as a change in the overall therapeutic concept (curative vs. palliative). Follow-up imaging and histological evaluation served as the gold standard. Mean tumour SUVs were determined by 1.5 cm regions of interest placed over the tumour's maximum. Results: when read independently from the CT scan FDG PET indicated a clinically relevant change in tumour stage in 9/40 patients (23%) and a non-relevant change in 11/40 patients (28%). PET was correct in 5/9 patients (56%) with clinically relevant discordances. In 4/9 patients PET was incorrect (3 false positive due to suspicion of MI-lymph nodes or lung metastases, 1 false negative in disseminated liver metastases). With concomitant reading, PET indicated a clinically relevant change in tumour stage in 6/40 patients (15%) and a non-relevant change in 5/40 patients (13%). PET was correct in 5/6 patients (83%) with clinically relevant discordances. The patient with disseminated liver disease remained the single false negative. Overall, the benefit from PET was based on its higher diagnostic accuracy at organ sites. Tumour SUV did not correlate with patient survival. Conclusion: about half of discordances between FDG PET and CT are clinically relevant

  19. Clinical relevance and biology of circulating tumor cells

    Science.gov (United States)

    2011-01-01

    Most breast cancer patients die due to metastases, and the early onset of this multistep process is usually missed by current tumor staging modalities. Therefore, ultrasensitive techniques have been developed to enable the enrichment, detection, isolation and characterization of disseminated tumor cells in bone marrow and circulating tumor cells in the peripheral blood of cancer patients. There is increasing evidence that the presence of these cells is associated with an unfavorable prognosis related to metastatic progression in the bone and other organs. This review focuses on investigations regarding the biology and clinical relevance of circulating tumor cells in breast cancer. PMID:22114869

  20. [Quality Management for Surgeons: The Knowledge of Basic Contexts and Innovative Strategies Promotes the Competitiveness of Clinical Department].

    Science.gov (United States)

    Hellmann, Wolfgang

    2017-12-01

    Efficient quality management aiming to achieve high quality in patient care is crucial to the success of a surgery department. This requires the knowledge of relevant terms und contexts of quality management. Implementation remains difficult in the light of demographic change and skills shortage. If a hospital has an efficient internal quality management in place, this should be used as a supplementary instrument. Otherwise it is the (sole) task of a specialist department to ensure quality for patients, employees, and cooperative partners. This paper provides basic knowledge on quality management, risk management, and quality assurance in the context of relevant medical terms. It demonstrates new ways for implementation on the level of a surgery department, and introduces a new model of quality. Georg Thieme Verlag KG Stuttgart · New York.

  1. Relationship between quality of care and choice of clinical computing system: retrospective analysis of family practice performance under the UK's quality and outcomes framework.

    Science.gov (United States)

    Kontopantelis, Evangelos; Buchan, Iain; Reeves, David; Checkland, Kath; Doran, Tim

    2013-08-02

    To investigate the relationship between performance on the UK Quality and Outcomes Framework pay-for-performance scheme and choice of clinical computer system. Retrospective longitudinal study. Data for 2007-2008 to 2010-2011, extracted from the clinical computer systems of general practices in England. All English practices participating in the pay-for-performance scheme: average 8257 each year, covering over 99% of the English population registered with a general practice. Levels of achievement on 62 quality-of-care indicators, measured as: reported achievement (levels of care after excluding inappropriate patients); population achievement (levels of care for all patients with the relevant condition) and percentage of available quality points attained. Multilevel mixed effects multiple linear regression models were used to identify population, practice and clinical computing system predictors of achievement. Seven clinical computer systems were consistently active in the study period, collectively holding approximately 99% of the market share. Of all population and practice characteristics assessed, choice of clinical computing system was the strongest predictor of performance across all three outcome measures. Differences between systems were greatest for intermediate outcomes indicators (eg, control of cholesterol levels). Under the UK's pay-for-performance scheme, differences in practice performance were associated with the choice of clinical computing system. This raises the question of whether particular system characteristics facilitate higher quality of care, better data recording or both. Inconsistencies across systems need to be understood and addressed, and researchers need to be cautious when generalising findings from samples of providers using a single computing system.

  2. Are data from national quality registries used in quality improvement at Swedish hospital clinics?

    Science.gov (United States)

    Fredriksson, Mio; Halford, Christina; Eldh, Ann Catrine; Dahlström, Tobias; Vengberg, Sofie; Wallin, Lars; Winblad, Ulrika

    2017-11-01

    To investigate the use of data from national quality registries (NQRs) in local quality improvement as well as purported key factors for effective clinical use in Sweden. Comparative descriptive: a web survey of all Swedish hospitals participating in three NQRs with different levels of development (certification level). Heads of the clinics and physician(s) at clinics participating in the Swedish Stroke Register (Riksstroke), the Swedish National Registry of Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks) and the Swedish Lung Cancer Registry (NLCR). Individual and unit level use of NQRs in local quality improvement, and perceptions on data quality, organizational conditions and user motivation. Riksstroke data were reported as most extensively used at individual and unit levels (x̅ 17.97 of 24 and x̅ 27.06 of 35). Data quality and usefulness was considered high for the two most developed NQRs (x̅ 19.86 for Riksstroke and x̅ 19.89 for GallRiks of 25). Organizational conditions were estimated at the same level for Riksstroke and GallRiks (x̅ 12.90 and x̅ 13.28 of 20) while the least developed registry, the NLCR, had lower estimates (x̅ 10.32). In Riksstroke, the managers requested registry data more often (x̅ 15.17 of 20). While there were significant differences between registries in key factors such as management interest, use of NQR data in local quality improvement seems rather prevalent, at least for Riksstroke. The link between the registry's level of development and factors important for routinization of innovations such as NQRs needs investigation. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  3. Mirror neurons and their clinical relevance.

    Science.gov (United States)

    Rizzolatti, Giacomo; Fabbri-Destro, Maddalena; Cattaneo, Luigi

    2009-01-01

    One of the most exciting events in neurosciences over the past few years has been the discovery of a mechanism that unifies action perception and action execution. The essence of this 'mirror' mechanism is as follows: whenever individuals observe an action being done by someone else, a set of neurons that code for that action is activated in the observers' motor system. Since the observers are aware of the outcome of their motor acts, they also understand what the other individual is doing without the need for intermediate cognitive mediation. In this Review, after discussing the most pertinent data concerning the mirror mechanism, we examine the clinical relevance of this mechanism. We first discuss the relationship between mirror mechanism impairment and some core symptoms of autism. We then outline the theoretical principles of neurorehabilitation strategies based on the mirror mechanism. We conclude by examining the relationship between the mirror mechanism and some features of the environmental dependency syndromes.

  4. Measuring service quality in a hospital colposcopy clinic.

    Science.gov (United States)

    Wisniewski, Mik; Wisniewski, Hazel

    2005-01-01

    The issues surrounding the measurement and provision of service quality in a health care setting are becoming increasingly important to nursing. This research study aims to apply the SERVQUAL measurement instrument in a Scottish colposcopy clinic. The study involved adapting the SERVQUAL instrument to the colposcopy setting and asking a sample of patients to complete the questionnaire. Patient expectations of service were obtained on first attendance at the clinic. Patient perceptions of service received were obtained on completion of treatment. Perceptions and expectations are then compared to identify where the largest service gaps exist. Although patient satisfaction with the overall service provided was generally high, the instrument provided evidence of where specific service improvements were needed. The largest service quality gap was for the reliability of service. The research also revealed the need for improved premises. Although the study has a limited sample size, it does appear that the SERVQUAL instrument has a useful diagnostic role to play in assessing and monitoring service quality in nursing, enabling nursing staff to identify where improvements are needed from the patients' perspective. The study has raised a number of issues which would form the basis for useful further research. Service quality from the patients' perspective should be routinely monitored and assessed. The findings should be useful to nursing staff seeking to assess, and improve, service quality.

  5. Variability in the quality of rectal cancer care in public hospitals in Catalonia (Spain): clinical audit as a basis for action.

    Science.gov (United States)

    Manchon-Walsh, P; Borras, J M; Espinas, J A; Aliste, L

    2011-04-01

    Clinical practice guidelines in cancer are a relevant component of Catalonian Cancer Strategy aimed at promoting equity of access to therapy and quality of cancer care. The colorectal cancer (CRC) guideline was first published in 2003 and subsequently updated in 2008. This study examined the quality of therapy administered to patients with rectal cancer in public hospitals in Catalonia (Spain) in 2005 and 2007, according to CRC guideline recommendations. We conducted a multicentre retrospective cohort study of patients who underwent curative-intent surgery for primary rectal cancer at Catalonian public hospitals in 2005 and 2007. Data were drawn from clinical records. The study covered 1831 patients with rectal cancer. Performance of total mesorectal excision (TME) was poorly reported by surgeons (46.4%) and pathologists (36.2%). Pre-operative radiotherapy was performed on 52% of stage-II and -III patients. Compared to high-caseload hospitals, those with a low caseload (≤11 cases/year) registered more Hartman's procedures, worse TME quality, a higher rate of post-operative complications and lower adherence to recommended pre-operative radio-chemotherapy. Reporting quality of care is essential for ascertaining current performance status and opportunities for improvement. In our case, there is a need for the quality of the information included in clinical records to be improved, and variability in adherence to guideline recommendations to be reduced. In view of the fact that heterogeneity in the quality of the health care process was linked to hospital caseload, the health authorities have decided to reorganise the provision of rectal cancer care. Copyright © 2011 Elsevier Ltd. All rights reserved.

  6. Conceptualising a system for quality clinical decision-making in ...

    African Journals Online (AJOL)

    As a feedback mechanism to promote or improve the quality of clinical decisions in nursing, standards for quality clinical decision-making are proposed in an exemplary manner. In addition, a system for quality clinical decisionmaking in nursing capitalises on the heritage of the nursing process. Considering the changes and ...

  7. Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

    Science.gov (United States)

    Davis, Judith A.

    A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

  8. Selecting clinical quality indicators for laboratory medicine.

    Science.gov (United States)

    Barth, Julian H

    2012-05-01

    Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

  9. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  10. Metabolism of psilocybin and psilocin: clinical and forensic toxicological relevance.

    Science.gov (United States)

    Dinis-Oliveira, Ricardo Jorge

    2017-02-01

    Psilocybin and psilocin are controlled substances in many countries. These are the two main hallucinogenic compounds of the "magic mushrooms" and both act as agonists or partial agonists at 5-hydroxytryptamine (5-HT) 2A subtype receptors. During the last few years, psilocybin and psilocin have gained therapeutic relevance but considerable physiological variability between individuals that can influence dose-response and toxicological profile has been reported. This review aims to discuss metabolism of psilocybin and psilocin, by presenting all major and minor psychoactive metabolites. Psilocybin is primarily a pro-drug that is dephosphorylated by alkaline phosphatase to active metabolite psilocin. This last is then further metabolized, psilocin-O-glucuronide being the main urinary metabolite with clinical and forensic relevance in diagnosis.

  11. Clinical relevance and scope of accidental extracoronary findings in coronary computed tomography angiography: A cardiac versus thoracic FOV study

    International Nuclear Information System (INIS)

    Aglan, Iman; Jodocy, Daniel; Hiehs, Stefan; Soegner, Peter; Frank, Renate; Haberfellner, Berhard; Klauser, Andrea; Jaschke, Werner; Feuchtner, Gudrun M.

    2010-01-01

    Objective: To assess the spectrum and clinical relevance of extracoronary findings in coronary CT angiography (CCTA), and to compare a small (cardiac) field of view (FOV) to a large (thoracic) FOV setting. Material and methods: 1084 consecutive patients (mean 57 years) with low-to-intermediate risk of coronary artery disease were enrolled. 542 CCTA scans were interpreted with small FOV (160-190 mm 2 ) encompassing the cardiac region. In another 542 CCTA (patients matched for age and gender), read-out of an additional full FOV (>320 mm 2 ) covering the thorax was performed. Clinical relevance of extracoronary findings was considered as either 'significant' or 'non-significant'. 'Significant' findings were subclassified as either score 1: findings necessitating immediate therapeutic actions, or score 2: findings with undoubted clinical or prognostic relevance, requiring clinical awareness, follow-up or further investigations (non-urgent). 'Non-significant' findings were assigned to either score 3: findings not requiring follow-up or further tests, or as score 4: irrelevant incidental findings. Results: Significantly more patients with extracoronary findings were identified by using a full FOV with 43.2% (234/542) compared to a small FOV with 33.6% (182/542) (p = 0.001). Similarly, a higher total number of extracoronary findings (n = 394) was found on full FOV compared to small FOV (n = 250) (p 2 aortic valve orifice area. Conclusions: The interpretation of extracoronary findings on CCTA scans is mandatory given high prevalence of clinically significant findings by using a full 'thoracic' FOV.

  12. Isolation, speciation, and antibiogram of clinically relevant non-diphtherial Corynebacteria (Diphtheroids

    Directory of Open Access Journals (Sweden)

    B S Reddy

    2012-01-01

    Full Text Available Purpose: Coryneform or the non-diphtherial Corynebacterium species largely remains a neglected group with the traditional consideration of these organisms as contaminants. This concept, however, is slowly changing in the light of recent observations. This study has been done to find out the species distribution and antibiogram of various members of the clinically relevant Coryneform group, isolated from various clinical materials. Materials and Methods: One hundred and fourteen non-duplicate isolates of diphtheroids from various clinical isolates were selected for the study. The isolates were identified to the species level by using a battery of tests; and antimicrobial susceptibility was tested by using a combination of Clinical and Laboratory Standards Institute (CLSI and the British Society for Antimicrobial Chemotherapy (BSAC guidelines, in the absence of definitive CLSI guidelines. Results: Corynebacterium amycolatum was the predominant species (35.9% in our series followed by the CDC Group G organisms (15.7%. Each of the remaining 19 species comprised of less than 10% of the isolates. More than half the total isolates were resistant to the penicillins, erythromycin, and clindamycin; while excellent activity (all the strains being susceptible was shown by vancomycin, linezolid, and tigecycline. Chloramphenicol and tetracycline also had good activity in inhibiting more than 80% of the isolates. Multiply drug resistance was exhibited by all the species. Conclusion: This study was an attempt to establish the clinical significance of coryneform organisms. The high level of resistance shown by this group to some of the common antibacterial agents highlights the importance of processing these isolates in select conditions to guide the clinicians towards an appropriate therapy.

  13. Clinical quality assurance in radiation oncology

    International Nuclear Information System (INIS)

    Anon.

    1991-01-01

    A quality assurance program in radiation oncology monitors and evaluates any departmental functions which have an impact on patient outcome. The ultimate purpose of the program is to maximize health benefit to the patient without a corresponding increase in risk. The foundation of the program should be the credo: at least do no harm, usually do some good and ideally realize the greatest good. The steep dose response relationships for tumor control and complications require a high degree of accuracy and precision throughout the entire process of radiation therapy. It has been shown that failure to control local disease with radiation may result in decreased survival and may increase the cost of care by a factor of 3. Therefore, a comprehensive quality assurance program which seeks to optimize dose delivery and which encompasses both clinical and physics components, is needed

  14. [Targeting high-risk drugs to optimize clinical pharmacists' intervention].

    Science.gov (United States)

    Mouterde, Anne-Laure; Bourdelin, Magali; Maison, Ophélie; Coursier, Sandra; Bontemps, Hervé

    2016-12-01

    By the Order of 6 April 2011, the pharmacist must validate all the prescriptions containing "high-risk drugs" or those of "patients at risk". To optimize this clinical pharmacy activity, we identified high-risk drugs. A list of high-risk drugs has been established using literature, pharmacists' interventions (PI) performed in our hospital and a survey sent to hospital pharmacists. In a prospective study (analysis of 100 prescriptions for each high-risk drug selected), we have identified the most relevant to target. We obtained a statistically significant PI rate (P<0.05) for digoxin, oral anticoagulants direct, oral methotrexate and colchicine. This method of targeted pharmaceutical validation based on high-risk drugs is relevant to detect patients with high risk of medicine-related illness. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  15. The effects of audit quality on the value relevance of other comprehensive incomes

    Directory of Open Access Journals (Sweden)

    Levinska Primavera

    2015-06-01

    Full Text Available Stockholders claim deals with handling crucial role to investors while another ac-counting measurement has not yet been paid attention by the investors and analysts. Beside, another comprehensive income despite of its equal role to net income also re-quires a deep concern. This research uses financial industry data in Indonesia Capital Market for 2011-2012 under panel method and also cross-section method as the addi-tional analysis. This research assesses the effect of audit quality on value relevance of other comprehensive income regarding subjectivity embedded in other comprehensive income components. These components are determined through fair value aspects, which eventually lead to management discretion in measuring other comprehensive income components. Subjective components of other comprehensive incomes consist of foreign exchange translation (forex, revaluation in fixed assets (rev, minimum pension liability adjustment (pen, and available-for-sale securities adjustment (sec. The audit quality is believed as a mechanism which can increase the value relevance of subjective of other comprehensive income components. On the other hand, when as-sessing the value relevance of other comprehensive income components both indivi-dually and in aggregate, it is encouraged by inconsistency of previous research results.

  16. Characterization of Metagenomes in Urban Aquatic Compartments Reveals High Prevalence of Clinically Relevant Antibiotic Resistance Genes in Wastewaters

    Directory of Open Access Journals (Sweden)

    Charmaine Ng

    2017-11-01

    Full Text Available The dissemination of antimicrobial resistance (AMR is an escalating problem and a threat to public health. Comparative metagenomics was used to investigate the occurrence of antibiotic resistant genes (ARGs in wastewater and urban surface water environments in Singapore. Hospital and municipal wastewater (n = 6 were found to have higher diversity and average abundance of ARGs (303 ARG subtypes, 197,816 x/Gb compared to treated wastewater effluent (n = 2, 58 ARG subtypes, 2,692 x/Gb and surface water (n = 5, 35 subtypes, 7,985 x/Gb. A cluster analysis showed that the taxonomic composition of wastewaters was highly similar and had a bacterial community composition enriched in gut bacteria (Bacteroides, Faecalibacterium, Bifidobacterium, Blautia, Roseburia, Ruminococcus, the Enterobacteriaceae group (Klebsiella, Aeromonas, Enterobacter and opportunistic pathogens (Prevotella, Comamonas, Neisseria. Wastewater, treated effluents and surface waters had a shared resistome of 21 ARGs encoding multidrug resistant efflux pumps or resistance to aminoglycoside, macrolide-lincosamide-streptogramins (MLS, quinolones, sulfonamide, and tetracycline resistance which suggests that these genes are wide spread across different environments. Wastewater had a distinctively higher average abundance of clinically relevant, class A beta-lactamase resistant genes (i.e., blaKPC, blaCTX-M, blaSHV, blaTEM. The wastewaters from clinical isolation wards, in particular, had a exceedingly high levels of blaKPC-2 genes (142,200 x/Gb, encoding for carbapenem resistance. Assembled scaffolds (16 and 30 kbp from isolation ward wastewater samples indicated this gene was located on a Tn3-based transposon (Tn4401, a mobilization element found in Klebsiella pneumonia plasmids. In the longer scaffold, transposable elements were flanked by a toxin–antitoxin (TA system and other metal resistant genes that likely increase the persistence, fitness and propagation of the plasmid in the

  17. Impairment of cocaine-mediated behaviours in mice by clinically relevant Ras-ERK inhibitors

    Science.gov (United States)

    Papale, Alessandro; Morella, Ilaria Maria; Indrigo, Marzia Tina; Bernardi, Rick Eugene; Marrone, Livia; Marchisella, Francesca; Brancale, Andrea; Spanagel, Rainer; Brambilla, Riccardo; Fasano, Stefania

    2016-01-01

    Ras-ERK signalling in the brain plays a central role in drug addiction. However, to date, no clinically relevant inhibitor of this cascade has been tested in experimental models of addiction, a necessary step toward clinical trials. We designed two new cell-penetrating peptides - RB1 and RB3 - that penetrate the brain and, in the micromolar range, inhibit phosphorylation of ERK, histone H3 and S6 ribosomal protein in striatal slices. Furthermore, a screening of small therapeutics currently in clinical trials for cancer therapy revealed PD325901 as a brain-penetrating drug that blocks ERK signalling in the nanomolar range. All three compounds have an inhibitory effect on cocaine-induced ERK activation and reward in mice. In particular, PD325901 persistently blocks cocaine-induced place preference and accelerates extinction following cocaine self-administration. Thus, clinically relevant, systemically administered drugs that attenuate Ras-ERK signalling in the brain may be valuable tools for the treatment of cocaine addiction. DOI: http://dx.doi.org/10.7554/eLife.17111.001 PMID:27557444

  18. IMPACT OF RESILIENCE, ICT SUPPORT AND QUALITY OF STUDENT'S LIFE ON QUALITY OF HIGH EDUCATION PROCESS

    Directory of Open Access Journals (Sweden)

    Zorica Lazic

    2016-12-01

    Full Text Available Answers to the questions of how and in what way the quality of life of students, resilience and ICT support affects the quality of high education we will get through this work where main objective is to define a network of processes and process management ensuring more quality and more innovative managing and service provision, therefore satisfying the needs of service users - in this case the students of the university. To collect the relevant data in the thematic analysis of this paper, the method of interviewing by questionnaires was applied. The sample survey was conducted among undergraduate students, teachers and staff of the Teacher Training Faculty in Uzice.

  19. Increasing clinical relevance in oral radiology: Benefits and challenges when implementing digital assessment.

    Science.gov (United States)

    de Lange, T; Møystad, A; Torgersen, G R

    2018-02-13

    The aims of the study were to investigate benefits and challenges in implementing a digital examination and study the clinical relevance of the digital examination in relation to clinical training and practice. The study was based on semi-structured focus-group interviews from two distinct student populations (2016 and 2017) in a bachelor programme in dental hygiene. In addition, conversational data from a plenary discussion from the whole second student population (2017) were collected and analysed. The data were approached on basis of content analysis. A benefit experienced in the digital examination was the ease in typing and editing answers on the computer. This suggests an increased effectiveness in computer-based compared to analogue examinations. An additional advantage was the experienced relevance of the examination related to the clinic. This finding refers not only to the digital presentations of images, but also to the entire setting in the clinic and dental practice. The limitations reported by the students were non-optimal viewing conditions for presenting radiographic images and difficulties in obtaining an overview of the assignments compared to paper-based examinations due to the linear digital examination format. The last finding on lacking overview revealed an influence on student performances which should be taken seriously in designing digital examinations. In conclusion, the digital layout increases efficiency and clinical relevance of examinations to a certain extent. Obstacles were found in limitations related to image presentation and lack of overview of the examination. The latter challenge raises questions related to developing suitable assessment software. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. [Quality assessment program of the Spanish Society of Infectious Diseases and Clinical Microbiology. Analysis of results. 2005].

    Science.gov (United States)

    Orta Mira, Nieves; Guna Serrano, M del Remedio; Pérez, José L; Gimeno Cardona, Concepción

    2006-10-01

    Quality assurance of the analytical processes performed at the clinical microbiology laboratory is mandatory and should be carried out by using external and internal quality control activities. External quality assessment programs allow intercomparison within laboratories, detection of errors, and evaluation of the suitability of some reagents or diagnostic kits for the purpose for which they were designed; these activities are also useful for continuous education. The program launched 15 years ago by the Spanish Society of Infectious Diseases and Clinical Microbiology is based on sending typified materials along with a clinical and microbiological case related to these control materials. The spectrum of the samples is broad, including bacteriology (monthly and three-monthly), serology, mycology, parasitology, mycobacteria, virology, and molecular microbiology. After receiving the results from the participants, the program organization delivers an individual certificate comparing the results with those of a reference laboratory. Additionally, a report is generated by analyzing all the results sent by the participants; laboratories are also sent review articles on the subject of each assessment as a tool for continuous education in clinical microbiology. In this article, the most relevant conclusions and lessons from the 2005 assessments are presented.

  1. Automatic identification of high impact articles in PubMed to support clinical decision making.

    Science.gov (United States)

    Bian, Jiantao; Morid, Mohammad Amin; Jonnalagadda, Siddhartha; Luo, Gang; Del Fiol, Guilherme

    2017-09-01

    The practice of evidence-based medicine involves integrating the latest best available evidence into patient care decisions. Yet, critical barriers exist for clinicians' retrieval of evidence that is relevant for a particular patient from primary sources such as randomized controlled trials and meta-analyses. To help address those barriers, we investigated machine learning algorithms that find clinical studies with high clinical impact from PubMed®. Our machine learning algorithms use a variety of features including bibliometric features (e.g., citation count), social media attention, journal impact factors, and citation metadata. The algorithms were developed and evaluated with a gold standard composed of 502 high impact clinical studies that are referenced in 11 clinical evidence-based guidelines on the treatment of various diseases. We tested the following hypotheses: (1) our high impact classifier outperforms a state-of-the-art classifier based on citation metadata and citation terms, and PubMed's® relevance sort algorithm; and (2) the performance of our high impact classifier does not decrease significantly after removing proprietary features such as citation count. The mean top 20 precision of our high impact classifier was 34% versus 11% for the state-of-the-art classifier and 4% for PubMed's® relevance sort (p=0.009); and the performance of our high impact classifier did not decrease significantly after removing proprietary features (mean top 20 precision=34% vs. 36%; p=0.085). The high impact classifier, using features such as bibliometrics, social media attention and MEDLINE® metadata, outperformed previous approaches and is a promising alternative to identifying high impact studies for clinical decision support. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Fungal Contaminants in Drinking Water Regulation? A Tale of Ecology, Exposure, Purification and Clinical Relevance

    Directory of Open Access Journals (Sweden)

    Monika Novak Babič

    2017-06-01

    Full Text Available Microbiological drinking water safety is traditionally monitored mainly by bacterial parameters that indicate faecal contamination. These parameters correlate with gastro-intestinal illness, despite the fact that viral agents, resulting from faecal contamination, are usually the cause. This leaves behind microbes that can cause illness other than gastro-intestinal and several emerging pathogens, disregarding non-endemic microbial contaminants and those with recent pathogenic activity reported. This white paper focuses on one group of contaminants known to cause allergies, opportunistic infections and intoxications: Fungi. It presents a review on their occurrence, ecology and physiology. Additionally, factors contributing to their presence in water distribution systems, as well as their effect on water quality are discussed. Presence of opportunistic and pathogenic fungi in drinking water can pose a health risk to consumers due to daily contact with water, via several exposure points, such as drinking and showering. The clinical relevance and influence on human health of the most common fungal contaminants in drinking water is discussed. Our goal with this paper is to place fungal contaminants on the roadmap of evidence based and emerging threats for drinking water quality safety regulations.

  3. Fungal Contaminants in Drinking Water Regulation? A Tale of Ecology, Exposure, Purification and Clinical Relevance

    Science.gov (United States)

    Novak Babič, Monika; Gunde-Cimerman, Nina; Vargha, Márta; Tischner, Zsófia; Magyar, Donát; Veríssimo, Cristina; Sabino, Raquel; Viegas, Carla; Meyer, Wieland; Brandão, João

    2017-01-01

    Microbiological drinking water safety is traditionally monitored mainly by bacterial parameters that indicate faecal contamination. These parameters correlate with gastro-intestinal illness, despite the fact that viral agents, resulting from faecal contamination, are usually the cause. This leaves behind microbes that can cause illness other than gastro-intestinal and several emerging pathogens, disregarding non-endemic microbial contaminants and those with recent pathogenic activity reported. This white paper focuses on one group of contaminants known to cause allergies, opportunistic infections and intoxications: Fungi. It presents a review on their occurrence, ecology and physiology. Additionally, factors contributing to their presence in water distribution systems, as well as their effect on water quality are discussed. Presence of opportunistic and pathogenic fungi in drinking water can pose a health risk to consumers due to daily contact with water, via several exposure points, such as drinking and showering. The clinical relevance and influence on human health of the most common fungal contaminants in drinking water is discussed. Our goal with this paper is to place fungal contaminants on the roadmap of evidence based and emerging threats for drinking water quality safety regulations.

  4. Clinical trial quality: From supervision to collaboration and beyond.

    Science.gov (United States)

    Meeker-O'Connell, Ann; Glessner, Coleen

    2018-02-01

    Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

  5. Linking clinical quality indicators to research evidence - a case study in asthma management for children.

    Science.gov (United States)

    Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B; Coiera, Enrico

    2017-07-21

    Clinical quality indicators are used to monitor the performance of healthcare services and should wherever possible be based on research evidence. Little is known however about the extent to which indicators in common use are based on research. The objective of this study is to measure the extent to which clinical quality indicators used in asthma management in children with outcome measurements can be linked to results in randomised controlled clinical trial (RCT) reports. This work is part of a broader research program to trial methods that improve the efficiency and accuracy of indicator development. National-level indicators for asthma management in children were extracted from the National Quality Measures Clearinghouse database and the National Institute for Health and Care Excellence quality standards by two independent appraisers. Outcome measures were extracted from all published English language RCT reports for asthma management in children below the age of 12 published between 2005 and 2014. The two sets were then linked by manually mapping both to a common set of Unified Medical Language System (UMLS) concepts. The analysis identified 39 indicators and 562 full text RCTs dealing with asthma management in children. About 95% (37/39) of the indicators could be linked to RCT outcome measures. It is possible to identify relevant RCT reports for the majority of indicators used to assess the quality of asthma management in childhood. The methods reported here could be automated to more generally support assessment of candidate indicators against the research evidence.

  6. Rating the strength of scientific evidence: relevance for quality improvement programs.

    Science.gov (United States)

    Lohr, Kathleen N

    2004-02-01

    To summarize an extensive review of systems for grading the quality of research articles and rating the strength of bodies of evidence, and to highlight for health professionals and decision-makers concerned with quality measurement and improvement the available "best practices" tools by which these steps can be accomplished. Drawing on an extensive review of checklists, questionnaires, and other tools in the field of evidence-based practice, this paper discusses clinical, management, and policy rationales for rating strength of evidence in a quality improvement context, and documents best practices methods for these tasks. After review of 121 systems for grading the quality of articles, 19 systems, mostly specific, met a priori scientific standards for grading systematic reviews, randomized controlled trials, observational studies, and diagnostic tests; eight systems (of 40 reviewed) met similar standards for rating the overall strength of evidence. All can be used as is or adapted for particular types of evidence reports or systematic reviews. Formally grading study quality and rating overall strength of evidence, using sound instruments and procedures, can produce reasonable levels of confidence about the science base for parts of quality improvement programs. With such information, health care professionals and administrators concerned with quality improvement can understand better the level of science (versus only clinical consensus or opinion) that supports practice guidelines, review criteria, and assessments that feed into quality assurance and improvement programs. New systems are appearing and research is needed to confirm the conceptual and practical underpinnings of these grading and rating systems, but the need for those developing systematic reviews, practice guidelines, and quality or audit criteria to understand and undertake these steps is becoming increasingly clear.

  7. Quality assurance in radiation therapy: clinical aspects

    International Nuclear Information System (INIS)

    Souhami, L.

    1984-01-01

    A survey was conducted in Latin America to evaluate the clinical aspects of quality assurance in radiotherapy. A questionnaire was prepared and sent to 46 institutions. Twenty-seven centers (58.5%), from nine countries, answered the questionnaire. The study was divided into three topics: a) patient-related statistics; b) staffing and education; and c) equipment and facilities. Radiotherapy training programs are available in only 37% of the centers studied. A large number of megavoltage units are old, operating at a shorter than optimum distance with sources of very low activity. The number of high energy linear accelerators is unsatisfactory. Problems in treatment planning facilities were also identified. Regionalization of radiation therapy services is recommended as a possible way to improve quality at a reasonable cost

  8. Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

    Science.gov (United States)

    Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E

    2013-01-01

    To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.

  9. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed) trials.

    Science.gov (United States)

    Paoloni, Melissa; Webb, Craig; Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E J; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara; Khanna, Chand; Trent, Jeffrey

    2014-01-01

    Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (strategies may aid cancer drug development.

  10. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  11. Clinical relevance of and risk factors associated with medication administration time errors

    NARCIS (Netherlands)

    Teunissen, R.; Bos, J.; Pot, H.; Pluim, M.; Kramers, C.

    2013-01-01

    PURPOSE: The clinical relevance of and risk factors associated with errors related to medication administration time were studied. METHODS: In this explorative study, 66 medication administration rounds were studied on two wards (surgery and neurology) of a hospital. Data on medication errors were

  12. Sleep quantity, quality, and insomnia symptoms of medical students during clinical years

    Science.gov (United States)

    Alsaggaf, Mohammed A.; Wali, Siraj O.; Merdad, Roah A.; Merdad, Leena A.

    2016-01-01

    Objectives: To determine sleep habits and sleep quality in medical students during their clinical years using validated measures; and to investigate associations with academic performance and psychological stress. Methods: In this cross-sectional study, medical students (n=320) were randomly selected from a list of all enrolled clinical-year students in a Saudi medical school from 2011-2012. Students filled a questionnaire including demographic and lifestyle factors, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and Perceived Stress Scale. Results: Students acquired on average, 5.8 hours of sleep each night, with an average bedtime at 01:53. Approximately 8% reported acquiring sleep during the day, and not during nighttime. Poor sleep quality was present in 30%, excessive daytime sleepiness (EDS) in 40%, and insomnia symptoms in 33% of students. Multivariable regression models revealed significant associations between stress, poor sleep quality, and EDS. Poorer academic performance and stress were associated with symptoms of insomnia. Conclusion: Sleep deprivation, poor sleep quality, and EDS are common among clinical years medical students. High levels of stress and the pressure of maintaining grade point averages may be influencing their quality of sleep. PMID:26837401

  13. Patient-reported symptoms during radiotherapy : Clinically relevant symptom burden in patients treated with palliative and curative intent.

    Science.gov (United States)

    Körner, Philipp; Ehrmann, Katja; Hartmannsgruber, Johann; Metz, Michaela; Steigerwald, Sabrina; Flentje, Michael; van Oorschot, Birgitt

    2017-07-01

    The benefits of patient-reported symptom assessment combined with integrated palliative care are well documented. This study assessed the symptom burden of palliative and curative-intent radiation oncology patients. Prior to first consultation and at the end of RT, all adult cancer patients planned to receive fractionated percutaneous radiotherapy (RT) were asked to answer the Edmonton Symptom Assessment Scale (ESAS; nine symptoms from 0 = no symptoms to 10 = worst possible symptoms). Mean values were used for curative vs. palliative and pre-post comparisons, and the clinical relevance was evaluated (symptom values ≥ 4). Of 163 participating patients, 151 patients (90.9%) completed both surveys (116 curative and 35 palliative patients). Before beginning RT, 88.6% of palliative and 72.3% of curative patients showed at least one clinically relevant symptom. Curative patients most frequently named decreased general wellbeing (38.6%), followed by tiredness (35.0%), anxiety (32.4%), depression (30.0%), pain (26.3%), lack of appetite (23.5%), dyspnea (17.8%), drowsiness (8.0%) and nausea (6.1%). Palliative patients most frequently named decreased general wellbeing (62.8%), followed by pain (62.8%), tiredness (60.0%), lack of appetite (40.0%), anxiety (38.0%), depression (33.3%), dyspnea (28.5%), drowsiness (25.7%) and nausea (14.2%). At the end of RT, the proportion of curative and palliative patients with a clinically relevant symptom had increased significantly to 79.8 and 91.4%, respectively; whereas the proportion of patients reporting clinically relevant pain had decreased significantly (42.8 vs. 62.8%, respectively). Palliative patients had significantly increased tiredness. Curative patients reported significant increases in pain, tiredness, nausea, drowsiness, lack of appetite and restrictions in general wellbeing. Assessment of patient-reported symptoms was successfully realized in radiation oncology routine. Overall, both groups showed a high symptom

  14. Patient-reported symptoms during radiotherapy. Clinically relevant symptom burden in patients treated with palliative and curative intent

    International Nuclear Information System (INIS)

    Koerner, Philipp; Ehrmann, Katja; Hartmannsgruber, Johann; Metz, Michaela; Steigerwald, Sabrina; Flentje, Michael; Oorschot, Birgitt van

    2017-01-01

    The benefits of patient-reported symptom assessment combined with integrated palliative care are well documented. This study assessed the symptom burden of palliative and curative-intent radiation oncology patients. Prior to first consultation and at the end of RT, all adult cancer patients planned to receive fractionated percutaneous radiotherapy (RT) were asked to answer the Edmonton Symptom Assessment Scale (ESAS; nine symptoms from 0 = no symptoms to 10 = worst possible symptoms). Mean values were used for curative vs. palliative and pre-post comparisons, and the clinical relevance was evaluated (symptom values ≥ 4). Of 163 participating patients, 151 patients (90.9%) completed both surveys (116 curative and 35 palliative patients). Before beginning RT, 88.6% of palliative and 72.3% of curative patients showed at least one clinically relevant symptom. Curative patients most frequently named decreased general wellbeing (38.6%), followed by tiredness (35.0%), anxiety (32.4%), depression (30.0%), pain (26.3%), lack of appetite (23.5%), dyspnea (17.8%), drowsiness (8.0%) and nausea (6.1%). Palliative patients most frequently named decreased general wellbeing (62.8%), followed by pain (62.8%), tiredness (60.0%), lack of appetite (40.0%), anxiety (38.0%), depression (33.3%), dyspnea (28.5%), drowsiness (25.7%) and nausea (14.2%). At the end of RT, the proportion of curative and palliative patients with a clinically relevant symptom had increased significantly to 79.8 and 91.4%, respectively; whereas the proportion of patients reporting clinically relevant pain had decreased significantly (42.8 vs. 62.8%, respectively). Palliative patients had significantly increased tiredness. Curative patients reported significant increases in pain, tiredness, nausea, drowsiness, lack of appetite and restrictions in general wellbeing. Assessment of patient-reported symptoms was successfully realized in radiation oncology routine. Overall, both groups showed a high symptom burden

  15. Ablation of clinically relevant kidney tissue volumes by high-intensity focused ultrasound: Preliminary results of standardized ex-vivo investigations.

    Science.gov (United States)

    Häcker, Axel; Peters, Kristina; Knoll, Thomas; Marlinghaus, Ernst; Alken, Peter; Jenne, Jürgen W; Michel, Maurice Stephan

    2006-11-01

    To investigate strategies to achieve confluent kidney-tissue ablation by high-intensity focused ultrasound (HIFU). Our model of the perfused ex-vivo porcine kidney was used. Tissue ablation was performed with an experimental HIFU device (Storz Medical, Kreuzlingen, Switzerland). Lesion-to-lesion interaction was investigated by varying the lesion distance (5 to 2.5 mm), generator power (300, 280, and 260 W), cooling time (10, 20, and 30 seconds), and exposure time (4, 3, and 2 seconds). The lesion rows were analyzed grossly and by histologic examination (hematoxylin-eosin and nicotinamide adenine dinucleotide staining). It was possible to achieve complete homogeneous ablation of a clinically relevant tissue volume but only by meticulous adjustment of the exposure parameters. Minimal changes in these parameters caused changes in lesion formation with holes within the lesions and lesion-to-lesion interaction. Our preliminary results show that when using this new device, HIFU can ablate a large tissue volume homogeneously in perfused ex-vivo porcine tissue under standardized conditions with meticulous adjustment of exposure parameters. Further investigations in vivo are necessary to test whether large tissue volumes can be ablated completely and reliably despite the influence of physiologic tissue and organ movement.

  16. Assessing Hospital Physicians' Acceptance of Clinical Information Systems: A Review of the Relevant Literature

    Directory of Open Access Journals (Sweden)

    Bram Pynoo

    2013-06-01

    Full Text Available In view of the tremendous potential benefits of clinical information systems (CIS for the quality of patient care; it is hard to understand why not every CIS is embraced by its targeted users, the physicians. The aim of this study is to propose a framework for assessing hospital physicians' CIS-acceptance that can serve as a guidance for future research into this area. Hereto, a review of the relevant literature was performed in the ISI Web-of-Science database. Eleven studies were withheld from an initial dataset of 797 articles. Results show that just as in business settings, there are four core groups of variables that influence physicians' acceptance of a CIS: its usefulness and ease of use, social norms, and factors in the working environment that facilitate use of the CIS (such as providing computers/workstations, compatibility between the new and existing system.... We also identified some additional variables as predictors of CIS-acceptance.

  17. [New medical device hospital assessment: what kind of clinical data?].

    Science.gov (United States)

    Beaussier, H; Junot, H; Lancrenon, S; Faure, P

    2012-01-01

    Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  18. THE VALUE RELEVANCE OF INTERNATIONAL ACCOUNTING STANDARD IMPLEMENTATION AND AUDIT QUALITY

    Directory of Open Access Journals (Sweden)

    Hanifa Zulhaimi

    2015-12-01

    Full Text Available The implementation of international accounting standards in Indonesia has significantly affected financial reporting. It increases information relevance for the investors because a fair value comprehensively represents assets and liabilities of an entity as of the balance sheet date. However, this triggers polemics over the value relevance of International Financial Reporting Standard (IFRS. This can be seen from stock price decline. This study aims to find out the effect of net income and other comprehensive income on stock price and to observe the effect of other comprehensive income moderated by audit quality. Furthermore this study also aims to find out the effect of  the subjectivity of OCI components. Using a sample of 79 companies, the writer analyzes 2014 financial statements derived from Indonesia Stock Exchange. Based on the result, the predetermined hypotheses are unable to prove. Net income is the only variable that affects stock return. Thus it can be concluded that net income has a value relevance for the investors in making economic decisions.

  19. Clinical relevance of the effects of reach-to-grasp training using trunk restraint in individuals with hemiparesis poststroke: A systematic review.

    Science.gov (United States)

    Greisberger, Andrea; Aviv, Hanna; Garbade, Sven F; Diermayr, Gudrun

    2016-04-28

    To evaluate the evidence for, and clinical relevance of, immediate and long-term effects of trunk restraint during reach-to-grasp training poststroke on movement patterns and functional abilities within the framework of the International Classification of Functioning, Disability and Health. PubMed, Web of Science, CINAHL, Embase, PEDro, Cochrane Library (publication dates January 1985 to March 2015). Randomized controlled trials comparing training using trunk restraint with any other exercise training. Data were extracted by one researcher and checked by two other researchers. The Cochrane Collaboration's tool for assessing risk of bias and the Physiotherapy Evidence Database scale were used by two researchers to assess study quality and risk of bias. Eight studies met the inclusion criteria. Five studies found better recovery of movement patterns (trunk displacement, elbow extension, and/or shoulder flexion - body function/structure) at post-test in the experimental compared with the control groups. Functional abilities (activity/participation) improved more in the experimental groups in 3 studies at post-test. Long-term effects were found in one study after 4 weeks. Trunk restraint has immediate and some long-term effects in adults with chronic stroke. However, these effects are not consistently clinically relevant when referring to minimal detectable change or minimal clinically important difference values.

  20. Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine

    DEFF Research Database (Denmark)

    Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred

    2017-01-01

    The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical...... to develop and maintain high quality "fit-for-purpose" IHC testing in the era of precision medicine. This is the final part of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."......The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical...... laboratories. There is a need for proper quality tools, specifically tissue tools that will enable laboratories to successfully carry out these processes. This paper clarifies, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed in order...

  1. Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example.

    Science.gov (United States)

    Bartels, Ronald H M A; Donk, Roland D; Verhagen, Wim I M; Hosman, Allard J F; Verbeek, André L M

    2017-11-01

    The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance. This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis. This study is a review of the literature. This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty. The outcome measure used in the study was the MCID. We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature. We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance. The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. A Vietnamese man with selective mutism: the relevance of multiple interacting 'cultures' in clinical psychiatry.

    Science.gov (United States)

    Hollifield, Michael; Geppert, Cynthia; Johnson, Yuam; Fryer, Carol

    2003-09-01

    Multiple cultural variables have effects on the psychobiology and behavioral manifestations of illness, as do patient and physician perceptions of illness. The interaction among these variables is at the heart of clinical psychiatry. This case of a Vietnamese man with selective mutism underscores the relevance of the 'cultures' of medicine, psychiatry, and war and trauma on the manifestations of illness and illness perceptions by patient and physician. The discussion focuses on how these cultures interact and play a crucial role in formulating diagnosis and treatment planning. Suggestions are given for shifts in medical education that will encourage relevant cultural paradigms to make their way into educational and clinical systems, which in turn should improve cultural competence in clinical psychiatry.

  3. Engaging Clinical Nurses in Quality Improvement Projects.

    Science.gov (United States)

    Moore, Susan; Stichler, Jaynelle F

    2015-10-01

    Clinical nurses have the knowledge and expertise required to provide efficient and proficient patient care. Time and knowledge deficits can prevent nurses from developing and implementing quality improvement or evidence-based practice projects. This article reviews a process for professional development of clinical nurses that helped them to define, implement, and analyze quality improvement or evidence-based practice projects. The purpose of this project was to educate advanced clinical nurses to manage a change project from inception to completion, using the Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) Change Acceleration Process as a framework. One-to-one mentoring and didactic in-services advanced the knowledge, appreciation, and practice of advanced practice clinicians who completed multiple change projects. The projects facilitated clinical practice changes, with improved patient outcomes; a unit cultural shift, with appreciation of quality improvement and evidence-based projects; and engagement with colleagues. Project outcomes were displayed in poster presentations at a hospital exposition for knowledge dissemination. Copyright 2015, SLACK Incorporated.

  4. Per-beam, planar IMRT QA passing rates do not predict clinically relevant patient dose errors

    International Nuclear Information System (INIS)

    Nelms, Benjamin E.; Zhen Heming; Tome, Wolfgang A.

    2011-01-01

    Purpose: The purpose of this work is to determine the statistical correlation between per-beam, planar IMRT QA passing rates and several clinically relevant, anatomy-based dose errors for per-patient IMRT QA. The intent is to assess the predictive power of a common conventional IMRT QA performance metric, the Gamma passing rate per beam. Methods: Ninety-six unique data sets were created by inducing four types of dose errors in 24 clinical head and neck IMRT plans, each planned with 6 MV Varian 120-leaf MLC linear accelerators using a commercial treatment planning system and step-and-shoot delivery. The error-free beams/plans were used as ''simulated measurements'' (for generating the IMRT QA dose planes and the anatomy dose metrics) to compare to the corresponding data calculated by the error-induced plans. The degree of the induced errors was tuned to mimic IMRT QA passing rates that are commonly achieved using conventional methods. Results: Analysis of clinical metrics (parotid mean doses, spinal cord max and D1cc, CTV D95, and larynx mean) vs IMRT QA Gamma analysis (3%/3 mm, 2/2, 1/1) showed that in all cases, there were only weak to moderate correlations (range of Pearson's r-values: -0.295 to 0.653). Moreover, the moderate correlations actually had positive Pearson's r-values (i.e., clinically relevant metric differences increased with increasing IMRT QA passing rate), indicating that some of the largest anatomy-based dose differences occurred in the cases of high IMRT QA passing rates, which may be called ''false negatives.'' The results also show numerous instances of false positives or cases where low IMRT QA passing rates do not imply large errors in anatomy dose metrics. In none of the cases was there correlation consistent with high predictive power of planar IMRT passing rates, i.e., in none of the cases did high IMRT QA Gamma passing rates predict low errors in anatomy dose metrics or vice versa. Conclusions: There is a lack of correlation between

  5. Proteomic Assessment of the Relevant Factors Affecting Pork Meat Quality Associated with Muscles in Duroc Pigs

    Directory of Open Access Journals (Sweden)

    Jin Hyoung Cho

    2016-11-01

    Full Text Available Meat quality is a complex trait influenced by many factors, including genetics, nutrition, feeding environment, animal handling, and their interactions. To elucidate relevant factors affecting pork quality associated with oxidative stress and muscle development, we analyzed protein expression in high quality longissimus dorsi muscles (HQLD and low quality longissimus dorsi muscles (LQLD from Duroc pigs by liquid chromatographytandem mass spectrometry (LC-MS/MS–based proteomic analysis. Between HQLD (n = 20 and LQLD (n = 20 Duroc pigs, 24 differentially expressed proteins were identified by LC-MS/MS. A total of 10 and 14 proteins were highly expressed in HQLD and LQLD, respectively. The 24 proteins have putative functions in the following seven categories: catalytic activity (31%, ATPase activity (19%, oxidoreductase activity (13%, cytoskeletal protein binding (13%, actin binding (12%, calcium ion binding (6%, and structural constituent of muscle (6%. Silver-stained image analysis revealed significant differential expression of lactate dehydrogenase A (LDHA between HQLD and LQLD Duroc pigs. LDHA was subjected to in vitro study of myogenesis under oxidative stress conditions and LDH activity assay to verification its role in oxidative stress. No significant difference of mRNA expression level of LDHA was found between normal and oxidative stress condition. However, LDH activity was significantly higher under oxidative stress condition than at normal condition using in vitro model of myogenesis. The highly expressed LDHA was positively correlated with LQLD. Moreover, LDHA activity increased by oxidative stress was reduced by antioxidant resveratrol. This paper emphasizes the importance of differential expression patterns of proteins and their interaction for the development of meat quality traits. Our proteome data provides valuable information on important factors which might aid in the regulation of muscle development and the improvement of

  6. Quality control of radiation therapy in clinical trials

    International Nuclear Information System (INIS)

    Kramer, S.; Lustig, R.; Grundy, G.

    1983-01-01

    The RTOG is a group of participating institutions which has a major interest in furthering clinical radiation oncology. They have formulated protocols for clinical investigation in which radiation therapy is the major modality of treatment. In addition, other modalities, such as chemotherapy, radiation sensitizers, and hyperthermia, are used in combined approach to cancer. Quality control in all aspects of patient management is necessary to insure quality data. These areas include evaluation of pathology, physics, and dosimetry, and clinical patient data. Quality control is both time consuming and expensive. However, by dividing these tasks into various levels and time frames, by using computerized data-control mechanisms, and by employing appropriate levels of ancillary personnel expertise, quality control can improve compliance and decrease the cost of investigational trials

  7. Ability to Work among Patients with ESKD: Relevance of Quality Care Metrics.

    Science.gov (United States)

    Kutner, Nancy G; Zhang, Rebecca

    2017-08-07

    Enabling patient ability to work was a key rationale for enacting the United States (US) Medicare program that provides financial entitlement to renal replacement therapy for persons with end-stage kidney disease (ESKD). However, fewer than half of working-age individuals in the US report the ability to work after starting maintenance hemodialysis (HD). Quality improvement is a well-established objective in oversight of the dialysis program, but a more patient-centered quality assessment approach is increasingly advocated. The ESKD Quality Incentive Program (QIP) initiated in 2012 emphasizes clinical performance indicators, but a newly-added measure requires the monitoring of patient depression-an issue that is important for work ability and employment. We investigated depression scores and four dialysis-specific QIP measures in relation to work ability reported by a multi-clinic cohort of 528 working-age maintenance HD patients. The prevalence of elevated depression scores was substantially higher among patients who said they were not able to work, while only one of the four dialysis-specific clinical measures differed for patients able/not able to work. Ability to work may be among patients' top priorities. As the parameters of quality assessment continue to evolve, increased attention to patient priorities might facilitate work ability and employment outcomes.

  8. Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors.

    Science.gov (United States)

    Kirkham, Amy A; Bland, Kelcey A; Sayyari, Sarah; Campbell, Kristin L; Davis, Margot K

    2016-02-01

    Evidence is currently limited for the effect of exercise on breast cancer clinical outcomes. However, several of the reported physical benefits of exercise, including peak oxygen consumption, functional capacity, muscle strength and lean mass, cardiovascular risk factors, and bone health, have established associations with disability, cardiovascular disease risk, morbidity, and mortality. This review will summarize the clinically relevant physical benefits of exercise interventions in breast cancer survivors and discuss recommendations for achieving these benefits. It will also describe potential differences in intervention delivery that may impact outcomes and, lastly, describe current physical activity guidelines for cancer survivors.

  9. Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation.

    Science.gov (United States)

    McMillan, Matthew T; Soi, Sameer; Asbun, Horacio J; Ball, Chad G; Bassi, Claudio; Beane, Joal D; Behrman, Stephen W; Berger, Adam C; Bloomston, Mark; Callery, Mark P; Christein, John D; Dixon, Elijah; Drebin, Jeffrey A; Castillo, Carlos Fernandez-Del; Fisher, William E; Fong, Zhi Ven; House, Michael G; Hughes, Steven J; Kent, Tara S; Kunstman, John W; Malleo, Giuseppe; Miller, Benjamin C; Salem, Ronald R; Soares, Kevin; Valero, Vicente; Wolfgang, Christopher L; Vollmer, Charles M

    2016-08-01

    To evaluate surgical performance in pancreatoduodenectomy using clinically relevant postoperative pancreatic fistula (CR-POPF) occurrence as a quality indicator. Accurate assessment of surgeon and institutional performance requires (1) standardized definitions for the outcome of interest and (2) a comprehensive risk-adjustment process to control for differences in patient risk. This multinational, retrospective study of 4301 pancreatoduodenectomies involved 55 surgeons at 15 institutions. Risk for CR-POPF was assessed using the previously validated Fistula Risk Score, and pancreatic fistulas were stratified by International Study Group criteria. CR-POPF variability was evaluated and hierarchical regression analysis assessed individual surgeon and institutional performance. There was considerable variability in both CR-POPF risk and occurrence. Factors increasing the risk for CR-POPF development included increasing Fistula Risk Score (odds ratio 1.49 per point, P ratio 3.30, P performance outliers were identified at the surgeon and institutional levels. Of the top 10 surgeons (≥15 cases) for nonrisk-adjusted performance, only 6 remained in this high-performing category following risk adjustment. This analysis of pancreatic fistulas following pancreatoduodenectomy demonstrates considerable variability in both the risk and occurrence of CR-POPF among surgeons and institutions. Disparities in patient risk between providers reinforce the need for comprehensive, risk-adjusted modeling when assessing performance based on procedure-specific complications. Furthermore, beyond inherent patient risk factors, surgical decision-making influences fistula outcomes.

  10. Costs and clinical quality among Medicare beneficiaries: associations with health center penetration of low-income residents.

    Science.gov (United States)

    Sharma, Ravi; Lebrun-Harris, Lydie A; Ngo-Metzger, Quyen

    2014-01-01

    Determine the association between access to primary care by the underserved and Medicare spending and clinical quality across hospital referral regions (HRRs). Data on elderly fee-for-service beneficiaries across 306 HRRs came from CMS' Geographic Variation in Medicare Spending and Utilization database (2010). We merged data on number of health center patients (HRSA's Uniform Data System) and number of low-income residents (American Community Survey). We estimated access to primary care in each HRR by "health center penetration" (health center patients as a proportion of low-income residents). We calculated total Medicare spending (adjusted for population size, local input prices, and health risk). We assessed clinical quality by preventable hospital admissions, hospital readmissions, and emergency department visits. We sorted HRRs by health center penetration rate and compared spending and quality measures between the high- and low-penetration deciles. We also employed linear regressions to estimate spending and quality measures as a function of health center penetration. The high-penetration decile had 9.7% lower Medicare spending ($926 per capita, p=0.01) than the low-penetration decile, and no different clinical quality outcomes. Compared with elderly fee-for-service beneficiaries residing in areas with low-penetration of health center patients among low-income residents, those residing in high-penetration areas may accrue Medicare cost savings. Limited evidence suggests that these savings do not compromise clinical quality.

  11. Ultrasound Image Quality Assessment: A framework for evaluation of clinical image quality

    DEFF Research Database (Denmark)

    Hemmsen, Martin Christian; Pedersen, Mads Møller; Nikolov, Svetoslav Ivanov

    2010-01-01

    Improvement of ultrasound images should be guided by their diagnostic value. Evaluation of clinical image quality is generally performed subjectively, because objective criteria have not yet been fully developed and accepted for the evaluation of clinical image quality. Based on recommendation 50...... information, which is fast enough to get sufficient number of scans under realistic operating conditions, so that statistical evaluation is valid and reliable....

  12. Motivation factors for suicidal behavior and their clinical relevance in admitted psychiatric patients.

    Directory of Open Access Journals (Sweden)

    Naoki Hayashi

    Full Text Available Suicidal behavior (SB is a major, worldwide health concern. To date there is limited understanding of the associated motivational aspects which accompany this self-initiated conduct.To develop a method for identifying motivational features associated with SB by studying admitted psychiatric patients, and to examine their clinical relevance.By performing a factor analytic study using data obtained from a patient sample exhibiting high suicidality and a variety of SB methods, Motivations for SB Scale (MSBS was constructed to measure the features. Data included assessments of DSM-IV psychiatric and personality disorders, suicide intent, depressive symptomatology, overt aggression, recent life events (RLEs and methods of SB, collated from structured interviews. Association of identified features with clinical variables was examined by correlation analyses and MANCOVA.Factor analyses elicited a 4-factor solution composed of Interpersonal-testing (IT, Interpersonal-change (IC, Self-renunciation (SR and Self-sustenance (SS. These factors were classified according to two distinctions, namely interpersonal vs. intra-personal directedness, and the level of assumed influence by SB or the relationship to prevailing emotions. Analyses revealed meaningful links between patient features and clinical variables. Interpersonal-motivations (IT and IC were associated with overt aggression, low suicidality and RLE discord or conflict, while SR was associated with depression, high suicidality and RLE separation or death. Borderline personality disorder showed association with IC and SS. When self-strangulation was set as a reference SB method, self-cutting and overdose-taking were linked to IT and SS, respectively.The factors extracted in this study largely corresponded to factors from previous studies, implying that they may be useful in a wider clinical context. The association of these features with SB-related factors suggests that they constitute an integral part

  13. Quality and relevance of master degree education for the professional development of nurses and midwives.

    Science.gov (United States)

    Massimi, Azzurra; Marzuillo, Carolina; Di Muzio, Marco; Vacchio, Maria Rosaria; D'Andrea, Elvira; Villari, Paolo; De Vito, Corrado

    2017-06-01

    Advanced education in nursing is essential to provide safe, high quality and efficient health services in line with population needs. However, there is an almost complete lack of studies on how nurses view the usefulness of post-graduate education for their current employment and for professional advancement. To evaluate how nurse graduates view the quality, relevance and applicability of the knowledge and skills acquired during the Master of Science in Nursing (MSN) degree. Multicentre cross-sectional study. A multicenter cross-sectional study was carried out through an online questionnaire mailed (July 2014-June 2015) to 560 nurses who obtained the MSN degree from 23 Italian universities in the academic year 2010-2011. A total of 426 nurses completed the survey (response rate 76.1%), 80% of whom believed they had acquired knowledge and skills useful in their professional life after graduation. A multiple logistic regression model highlighted the characteristics of nurse graduates who judged the master's course relevant for their present role. In brief, they are expert nurses (OR=3.41, 95% CI=1.54-7.54) who achieved professional growth after the course (OR=5.25, 95% CI=2.67-10.33) and who judged the course very good or excellent (OR=2.16, 95% CI=1.04-4.52). Only 8% of the respondents achieved a full professional growth after the course. In Italy, MSN courses are able to provide a high level of skills and competencies. However, given the low rate of professional growth after the course, specific policies should increase the employment rates of new master's graduate nurses. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.

    Science.gov (United States)

    Tatarewicz, Suzanna M; Mytych, Daniel T; Manning, Marta Starcevic; Swanson, Steven J; Moxness, Michael S; Chirmule, Narendra

    2014-06-01

    All therapeutic proteins have the potential to induce anti-drug antibodies (ADA). Clinically relevant ADA can impact efficacy and/or safety of a biological therapeutic. Immunogenicity assessment strategy evaluates binding and neutralizing ADA, and the need for additional characterization (e.g., epitope, titer and so on) is determined using a risk-based approach. The choice of characterization assays depends on the type, application and immunogenicity of the therapeutic. ADA characterization can impact the interpretation of the risk profile of a given therapeutic, and offers insight into opportunities for risk mitigation and management. This article describes common ADA characterization methods. Strategic assessment and characterization of clinically relevant ADA are discussed, in order to support clinical options for safe and effective patient care and disease management.

  15. Top studies relevant to primary care practice.

    Science.gov (United States)

    Perry, Danielle; Kolber, Michael R; Korownyk, Christina; Lindblad, Adrienne J; Ramji, Jamil; Ton, Joey; Allan, G Michael

    2018-04-01

    To summarize 10 high-quality studies from 2017 that have strong relevance to primary care practice. Study selection involved routine literature surveillance by a group of primary care health professionals. This included screening abstracts of important journals and Evidence Alerts, as well as searching the American College of Physicians Journal Club. Topics of the 2017 articles include whether treating subclinical hypothyroidism improves outcomes or symptoms; whether evolocumab reduces cardiovascular disease as well as low-density lipoprotein levels; whether lifestyle interventions reduce medication use in patients with diabetes; whether vitamin D prevents cardiovascular disease, cancer, or upper respiratory tract infections; whether canagliflozin reduces clinical events in patients with diabetes; how corticosteroid injections affect knee osteoarthritis; whether drained abscesses benefit from antibiotic treatment; whether patients with diabetes benefit from bariatric surgery; whether exenatide reduces clinical events in patients with diabetes; and whether tympanostomy tubes affect outcomes in recurrent acute otitis media or chronic otitis media. We provide brief summaries, context where needed, and final recommendations for 10 studies with potential effects on primary care. We also briefly review 5 "runner-up" studies. Research from 2017 produced several high-quality studies in diabetes management. These have demonstrated benefit for alternative therapies and offered evidence not previously available. This year's selection of studies also provided information on a variety of conditions and therapies that are, or might become, more common in primary care settings. Copyright© the College of Family Physicians of Canada.

  16. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects

    DEFF Research Database (Denmark)

    Watt, Torquil; Cramon, Per; Hegedüs, Laszlo

    2014-01-01

    responsiveness of the thyroid-related quality of life (QoL) instrument ThyPRO in patients undergoing relevant clinical treatments for benign thyroid diseases and to compare it with responsiveness of the generic SF-36 Health Survey. METHODS: A sample of 435 patients undergoing treatment completed the ThyPRO...... nontoxic goiter treated with surgery or radioactive iodine and remaining euthyroid (n = 62). Changes in QoL were evaluated in terms of effect size and compared to the changes predicted by clinical experts. The responsiveness of equivalent scales from ThyPRO and SF-36 Health Survey were compared...... with the relative validity index. RESULTS: The ThyPRO demonstrated good responsiveness across the whole range of QoL aspects in patients with hyper- and hypothyroidism. Responsiveness to treatment of nontoxic goiter was also demonstrated for physical and mental symptoms and overall QoL, but not for impact on social...

  17. A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

    Science.gov (United States)

    Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

    2018-05-15

    To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

  18. Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

    Science.gov (United States)

    Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

    2014-10-01

    Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

  19. Identifying clinically relevant drug resistance genes in drug-induced resistant cancer cell lines and post-chemotherapy tissues.

    Science.gov (United States)

    Tong, Mengsha; Zheng, Weicheng; Lu, Xingrong; Ao, Lu; Li, Xiangyu; Guan, Qingzhou; Cai, Hao; Li, Mengyao; Yan, Haidan; Guo, You; Chi, Pan; Guo, Zheng

    2015-12-01

    Until recently, few molecular signatures of drug resistance identified in drug-induced resistant cancer cell models can be translated into clinical practice. Here, we defined differentially expressed genes (DEGs) between pre-chemotherapy colorectal cancer (CRC) tissue samples of non-responders and responders for 5-fluorouracil and oxaliplatin-based therapy as clinically relevant drug resistance genes (CRG5-FU/L-OHP). Taking CRG5-FU/L-OHP as reference, we evaluated the clinical relevance of several types of genes derived from HCT116 CRC cells with resistance to 5-fluorouracil and oxaliplatin, respectively. The results revealed that DEGs between parental and resistant cells, when both were treated with the corresponding drug for a certain time, were significantly consistent with the CRG5-FU/L-OHP as well as the DEGs between the post-chemotherapy CRC specimens of responders and non-responders. This study suggests a novel strategy to extract clinically relevant drug resistance genes from both drug-induced resistant cell models and post-chemotherapy cancer tissue specimens.

  20. Effects of clinically relevant doses of methyphenidate on spatial memory, behavioral sensitization and open field habituation: a time related study.

    Science.gov (United States)

    Haleem, Darakhshan Jabeen; Inam, Qurrat-ul-Aen; Haleem, Muhammad Abdul

    2015-03-15

    The psychostimulant methylphenidate (MPD) is a first-line drug for the treatment of attention deficit hyperactivity disorder (ADHD). Despite acceptable therapeutic efficacy, there is limited data regarding the long-term consequences of MPD exposure over extended periods. The present study concerns effects of clinically relevant doses of MPD, administered orally to rats for an extended period, on spatial memory, behavioral sensitization and habituation to an open field. Water maze test was used to monitor memory acquisition (2 h after training), retention (day next to training), extinction (1 week after training) and reconsolidation (weekly for 4 weeks). Administration of MPD at doses of 0.25-1.0 mg/kg improved memory acquisition, retention, reconsolidation and impaired memory extinction. Treatment with 0.25 and 0.5 mg/kg MPD for 6 weeks produced a sustained increase in motor activity but higher dose (1.0 mg/kg) elicited behavioral sensitization. High as well as low doses MPD impaired open field habituation. We conclude that clinically relevant doses of MPD enhance memory even if used for extended period. It is suggested that higher (1.0 mg/kg) clinically relevant doses of MPD, if used for extended period, may exacerbate hyperactivity and impulsivity associated with the disease. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting

    DEFF Research Database (Denmark)

    Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor

    2017-01-01

    Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal...... and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft...... enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat...

  2. Dissociative absorption: An empirically unique, clinically relevant, dissociative factor.

    Science.gov (United States)

    Soffer-Dudek, Nirit; Lassri, Dana; Soffer-Dudek, Nir; Shahar, Golan

    2015-11-01

    Research of dissociative absorption has raised two questions: (a) Is absorption a unique dissociative factor within a three-factor structure, or a part of one general dissociative factor? Even when three factors are found, the specificity of the absorption factor is questionable. (b) Is absorption implicated in psychopathology? Although commonly viewed as "non-clinical" dissociation, absorption was recently hypothesized to be specifically associated with obsessive-compulsive symptoms. To address these questions, we conducted exploratory and confirmatory factor analyses on 679 undergraduates. Analyses supported the three-factor model, and a "purified" absorption scale was extracted from the original inclusive absorption factor. The purified scale predicted several psychopathology scales. As hypothesized, absorption was a stronger predictor of obsessive-compulsive symptoms than of general psychopathology. In addition, absorption was the only dissociative scale that longitudinally predicted obsessive-compulsive symptoms. We conclude that absorption is a unique and clinically relevant dissociative tendency that is particularly meaningful to obsessive-compulsive symptoms. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Clinical relevance of routinely measured vital signs in hospitalized patients: a systematic review

    NARCIS (Netherlands)

    Storm-Versloot, Marja N.; Verweij, Lotte; Lucas, Cees; Ludikhuize, Jeroen; Goslings, J. Carel; Legemate, Dink A.; Vermeulen, Hester

    2014-01-01

    Conflicting evidence exists on the effectiveness of routinely measured vital signs on the early detection of increased probability of adverse events. To assess the clinical relevance of routinely measured vital signs in medically and surgically hospitalized patients through a systematic review.

  4. [Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    Science.gov (United States)

    Ruiz de Gopegui Bordes, Enrique; Serrano, M del Remedio Guna; Orta Mira, Nieves; Ovies, María Rosario; Poveda, Marta; Cardona, Concepción Gimeno

    2011-12-01

    The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons of the 2010 controls. As a whole, the results obtained in 2010 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls to ensure maximal quality of microbiological tests(1). Copyright © 2011 Elsevier España S.L. All rights reserved.

  5. A conscious mouse model of gastric ileus using clinically relevant endpoints

    Directory of Open Access Journals (Sweden)

    Shao Yuanlin

    2005-06-01

    Full Text Available Abstract Background Gastric ileus is an unsolved clinical problem and current treatment is limited to supportive measures. Models of ileus using anesthetized animals, muscle strips or isolated smooth muscle cells do not adequately reproduce the clinical situation. Thus, previous studies using these techniques have not led to a clear understanding of the pathophysiology of ileus. The feasibility of using food intake and fecal output as simple, clinically relevant endpoints for monitoring ileus in a conscious mouse model was evaluated by assessing the severity and time course of various insults known to cause ileus. Methods Delayed food intake and fecal output associated with ileus was monitored after intraperitoneal injection of endotoxin, laparotomy with bowel manipulation, thermal injury or cerulein induced acute pancreatitis. The correlation of decreased food intake after endotoxin injection with gastric ileus was validated by measuring gastric emptying. The effect of endotoxin on general activity level and feeding behavior was also determined. Small bowel transit was measured using a phenol red marker. Results Each insult resulted in a transient and comparable decrease in food intake and fecal output consistent with the clinical picture of ileus. The endpoints were highly sensitive to small changes in low doses of endotoxin, the extent of bowel manipulation, and cerulein dose. The delay in food intake directly correlated with delayed gastric emptying. Changes in general activity and feeding behavior were insufficient to explain decreased food intake. Intestinal transit remained unchanged at the times measured. Conclusion Food intake and fecal output are sensitive markers of gastric dysfunction in four experimental models of ileus. In the mouse, delayed gastric emptying appears to be the major cause of the anorexic effect associated with ileus. Gastric dysfunction is more important than small bowel dysfunction in this model. Recovery of

  6. Wellbeing Understanding in High Quality Healthcare Informatics and Telepractice.

    Science.gov (United States)

    Fiorini, Rodolfo A; De Giacomo, Piero; L'Abate, Luciano

    2016-01-01

    The proper use of healthcare informatics technology and multidimensional conceptual clarity are fundamental to create and boost outstanding clinical and telepractice results. Avoiding even terminology ambiguities is mandatory for high quality of care service. For instance, well-being or wellbeing is a different way to write the same concept only, or there is a good deal of ambiguity around the meanings of these terms the way they are written. In personal health, healthcare and healthcare informatics, this kind of ambiguity and lack of conceptual clarity has been called out repeatedly over the past 50 years. It is time to get the right, terse scenario. We present a brief review to develop and achieve ultimate wellbeing understanding for practical high quality healthcare informatics and telepractice application. This article presents an innovative point of view on deeper wellbeing understanding towards its increased clinical effective application.

  7. Clinical trial of telepathology as an alternative modality in breast histopathology quality assurance.

    Science.gov (United States)

    Leong, F J; Graham, A K; Schwarzmann, P; McGee, J O

    2000-01-01

    Telepathology is a potential alternative to conventional histopathology. A clinical trial using a robotic telepathology system was conducted to assess the clinical and technical utility and effectiveness of telepathology in the U.K. breast screening pathology quality assurance program. Eighty-seven cases of breast disease were chosen at random from a series of 192 cases from the U.K. Breast Screening Pathology National Quality Assurance Scheme (NEQAS) collection. There were 20 benign, 23 carcinoma in situ (CIS), and 44 invasive malignant cases. The diagnostic accuracy of telepathology (TP) compared with conventional light microscopic (LM) diagnosis was 98.8%; this included a single case deferred for LM examination. The figure was similar when compared with expert consensus diagnosis (CD). In invasive tumor typing, TP accuracy was 95.4% (42/44 cases), the difference being attributable to slide color fading and would have had no impact on patient management. The accuracy of TP versus LM and expert consensus in tumor grading was 91.3% for carcinoma in situ (21/23 cases), a discordance with no relevance to patient management. TP grading of invasive tumor compared with LM diagnosis, had an accuracy of 86.4% (38/44) with a clinically significant accuracy of 97.7% (43/44). The time taken for TP diagnosis averaged 3.9 minutes per case by the end of the study. This data demonstrates that telepathology diagnostic accuracy is comparable to conventional microscopy and may therefore be envisaged as an alternative to conventional light microscopy for more rapid proficiency testing in breast screening (and perhaps other) quality assurance schemes.

  8. Implementation of Departmental Quality Strategies Is Positively Associated with Clinical Practice: Results of a Multicenter Study in 73 Hospitals in 7 European Countries.

    Science.gov (United States)

    Sunol, Rosa; Wagner, Cordula; Arah, Onyebuchi A; Kristensen, Solvejg; Pfaff, Holger; Klazinga, Niek; Thompson, Caroline A; Wang, Aolin; DerSarkissian, Maral; Bartels, Paul; Michel, Philippe; Groene, Oliver

    2015-01-01

    Given the amount of time and resources invested in implementing quality programs in hospitals, few studies have investigated their clinical impact and what strategies could be recommended to enhance its effectiveness. To assess variations in clinical practice and explore associations with hospital- and department-level quality management systems. Multicenter, multilevel cross-sectional study. Seventy-three acute care hospitals with 276 departments managing acute myocardial infarction, deliveries, hip fracture, and stroke in seven countries. None. Predictor variables included 3 hospital- and 4 department-level quality measures. Six measures were collected through direct observation by an external surveyor and one was assessed through a questionnaire completed by hospital quality managers. Dependent variables included 24 clinical practice indicators based on case note reviews covering the 4 conditions (acute myocardial infarction, deliveries, hip fracture and stroke). A directed acyclic graph was used to encode relationships between predictors, outcomes, and covariates and to guide the choice of covariates to control for confounding. Data were provided on 9021 clinical records by 276 departments in 73 hospitals. There were substantial variations in compliance with the 24 clinical practice indicators. Weak associations were observed between hospital quality systems and 4 of the 24 indicators, but on analyzing department-level quality systems, strong associations were observed for 8 of the 11 indicators for acute myocardial infarction and stroke. Clinical indicators supported by higher levels of evidence were more frequently associated with quality systems and activities. There are significant gaps between recommended standards of care and clinical practice in a large sample of hospitals. Implementation of department-level quality strategies was significantly associated with good clinical practice. Further research should aim to develop clinically relevant quality

  9. Implementation of Departmental Quality Strategies Is Positively Associated with Clinical Practice: Results of a Multicenter Study in 73 Hospitals in 7 European Countries

    Science.gov (United States)

    2015-01-01

    associated with good clinical practice. Further research should aim to develop clinically relevant quality standards for hospital departments, which appear to be more effective than generic hospital-wide quality systems. PMID:26588842

  10. Analysis of quality data based on national clinical databases

    DEFF Research Database (Denmark)

    Utzon, Jan; Petri, A.L.; Christophersen, S.

    2009-01-01

    extent the selection of patients, random variation, confounding and inconsistency may have influenced results. The aim of this article is to summarize aspects of clinical healthcare data analyses provided from the national clinical quality databases and to show how data may be presented in a way which......There is little agreement on the philosophy of measuring clinical quality in health care. How data should be analyzed and transformed to healthcare information is an ongoing discussion. To accept a difference in quality between health departments as a real difference, one should consider to which...

  11. Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review

    DEFF Research Database (Denmark)

    Campana, LG; Clover, AJ; Valpione, S

    2016-01-01

    Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting re...... studies and to provide the recommendations for reporting clinical trials on electrochemotherapy....... results, which should strengthen evidence-based practice recommendations. This consensus should be derived from high quality clinical data collection, clinical expertise and summarizing patient feedback. The first step, which is addressed in this paper, aims to critically analyze the quality of published...

  12. Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting: A Systematic Review.

    Science.gov (United States)

    Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor; Herly, Mikkel; Trojahn Kølle, Stig-Frederik; Fischer-Nielsen, Anne; Drzewiecki, Krzysztof Tadeusz

    2017-07-01

    Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat grafting. Improvements in graft retention, the SVF to fat (SVF:fat) ratio, and the ASC concentration used for enrichment were emphasized. We proposed an increased retention rate greater than 1.5-fold relative to nonenriched grafts and a maximum SVF:fat ratio of 1:1 as the thresholds for clinical relevance and feasibility, respectively. Nine studies fulfilled these criteria, whereof 6 used ASCs for enrichment. We found no convincing evidence of a clinically relevant effect of SVF enrichment in humans. ASC enrichment has shown promising results in enhancing graft retention, but additional clinical trials are needed to substantiate this claim and also determine the optimal concentration of SVF cells/ASCs for enrichment. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  13. Per-beam, planar IMRT QA passing rates do not predict clinically relevant patient dose errors

    Energy Technology Data Exchange (ETDEWEB)

    Nelms, Benjamin E.; Zhen Heming; Tome, Wolfgang A. [Canis Lupus LLC and Department of Human Oncology, University of Wisconsin, Merrimac, Wisconsin 53561 (United States); Department of Medical Physics, University of Wisconsin, Madison, Wisconsin 53705 (United States); Departments of Human Oncology, Medical Physics, and Biomedical Engineering, University of Wisconsin, Madison, Wisconsin 53792 (United States)

    2011-02-15

    Purpose: The purpose of this work is to determine the statistical correlation between per-beam, planar IMRT QA passing rates and several clinically relevant, anatomy-based dose errors for per-patient IMRT QA. The intent is to assess the predictive power of a common conventional IMRT QA performance metric, the Gamma passing rate per beam. Methods: Ninety-six unique data sets were created by inducing four types of dose errors in 24 clinical head and neck IMRT plans, each planned with 6 MV Varian 120-leaf MLC linear accelerators using a commercial treatment planning system and step-and-shoot delivery. The error-free beams/plans were used as ''simulated measurements'' (for generating the IMRT QA dose planes and the anatomy dose metrics) to compare to the corresponding data calculated by the error-induced plans. The degree of the induced errors was tuned to mimic IMRT QA passing rates that are commonly achieved using conventional methods. Results: Analysis of clinical metrics (parotid mean doses, spinal cord max and D1cc, CTV D95, and larynx mean) vs IMRT QA Gamma analysis (3%/3 mm, 2/2, 1/1) showed that in all cases, there were only weak to moderate correlations (range of Pearson's r-values: -0.295 to 0.653). Moreover, the moderate correlations actually had positive Pearson's r-values (i.e., clinically relevant metric differences increased with increasing IMRT QA passing rate), indicating that some of the largest anatomy-based dose differences occurred in the cases of high IMRT QA passing rates, which may be called ''false negatives.'' The results also show numerous instances of false positives or cases where low IMRT QA passing rates do not imply large errors in anatomy dose metrics. In none of the cases was there correlation consistent with high predictive power of planar IMRT passing rates, i.e., in none of the cases did high IMRT QA Gamma passing rates predict low errors in anatomy dose metrics or vice versa

  14. First branchial cleft anomaly: clinical insight into its relevance in otolaryngology with pediatric considerations.

    Science.gov (United States)

    Maithani, Tripti; Pandey, Apporva; Dey, Debraj; Bhardwaj, Aparna; Singh, V P

    2014-01-01

    First branchial cleft anomalies (FBCA) represent a small subset of congenital malformations in neck. Prime objective of this study is to share our experience with FBCA, emphasize its relevance in otolaryngology and deal with its pediatric perspective. Embryology, pathologic anatomy and varied spectra of clinical presentations of FBCA are discussed. Along with this we have illustrated three different cases; all of them were of pediatric age group and were misdiagnosed by their treating specialists elsewhere. In this article we have also laid special emphasis on its pediatric considerations. FBCA are mostly misdiagnosed due to their unfamiliar clinical signs and symptoms. Swellings may masquerade as other neck masses. Majority of patients give a history of previous incision and drainage. While dealing with pediatric patients the important factors to be kept in mind are the age of child, superficial course of facial nerve, any associated agenesis of parotid gland. Alteration in surgical technique may be required in children. A thorough medical examination with high index of clinical suspicion should be kept in mind while dealing with such anomalies. Owing to their complex presentation and close relation with facial nerve they are challenging lesions for surgeons.

  15. Clinical relevance of positive voltage-gated potassium channel (VGKC)-complex antibodies: experience from a tertiary referral centre.

    Science.gov (United States)

    Paterson, Ross W; Zandi, Michael S; Armstrong, Richard; Vincent, Angela; Schott, Jonathan M

    2014-06-01

    Voltage-gated potassium channel (VGKC)-complex antibodies can be associated with a range of immunotherapy-responsive clinical presentations including limbic encephalitis, Morvan's syndrome and acquired neuromyotonia. However, there are patients with positive levels in whom the significance is uncertain. To evaluate the clinical significance associated with positive (>100 pM) VGKC-complex antibodies. Over a 4-year period, 1053 samples were sent for testing of which 55 were positive. The clinical presentations, final diagnoses and responses to immunotherapies, when given, were assessed retrospectively and the likelihood of autoimmunity was categorised as definite, possible, unlikely or undetermined (modified from Zuliani et al 2012). Only 4 of the 32 patients with low-positive (100-400 pM) levels were considered definitely autoimmune, 3 with peripheral nerve hyperexcitability and 1 with a thymoma; 3 were given immunotherapies. Of the remaining 28 with low-positive levels, 13 (3 of whom had tumours) were considered possibly autoimmune, and 15 were unlikely or undetermined; 1 was given immunotherapy unsuccessfully. Of the 23 patients with high-positive (>400 pM) levels, 12 were given immunotherapies, 11 of whom showed a good response. 11 were considered definitely autoimmune, 10 with limbic encephalitis (antibody specificity: 5 LGI1, 1 contactin2, 2 negative, 2 untested) and 1 with a tumour. In the remaining 12, autoimmunity was considered possible (n=9; most had not received immunotherapies), or unlikely (n=3). As antibody testing becomes more widely available, and many samples are referred from patients with less clear-cut diagnoses, it is important to assess the utility of the results. VGKC-complex antibodies in the range of 100-400 pM (0.1-0.4 nM) were considered clinically relevant in rare conditions with peripheral nerve hyperexcitability and appeared to associate with tumours (12.5%). By contrast high-positive (>400 pM; >0.4 nM) levels were considered definitely

  16. Quality documentation challenges for veterinary clinical pathology laboratories.

    Science.gov (United States)

    Sacchini, Federico; Freeman, Kathleen P

    2008-05-01

    An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.

  17. Advances on the molecular characterization, clinical relevance, and detection methods of Gadiform parvalbumin allergens.

    Science.gov (United States)

    Fernandes, Telmo J R; Costa, Joana; Carrapatoso, Isabel; Oliveira, Maria Beatriz P P; Mafra, Isabel

    2017-10-13

    Gadiform order includes several fish families, from which Gadidae and Merlucciidae are part of, comprising the most commercially important and highly appreciated fish species, such as cod, pollock, haddock, and hake. Parvalbumins, classified as calcium-binding proteins, are considered the main components involved in the majority of fish allergies. Nine and thirteen parvalbumins were identified in different fish species from Gadidae and Merlucciidae families, respectively. This review intends to describe their molecular characterization and the clinical relevance, as well as the prevalence of fish allergy. In addition, the main protein- and DNA-based methods to detect fish allergens are fully reviewed owing to their importance in the safeguard of sensitized/allergic individuals.

  18. Clinical audit and quality systems - practical implementation in Finland

    International Nuclear Information System (INIS)

    Jaervinen, H.

    2003-01-01

    Clinical audit is a new concept of significant importance for the quality of radiological practices, introduced by the EC Medical Exposure Directive (MED, 97/43/EURATOM). By definition, clinical audit means 'a systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care, through structured review whereby radiological practices, procedures, and results are examined against agreed standards for good medical radiological procedures, with modifications of the practices where indicated and the application of new standards if necessary'. In its most profound meaning, being introduced in the medical exposure directive, clinical audit can be seen as a review of the success in implementing the justification and optimization principles, and therefore, it is to a large extent an issue of radiation safety for the patient. According to the directive, clinical audits shall be 'carried out in accordance with national procedures'. For the last few years, parallel to the development of the MED in Europe, there has been a worldwide tendency to implement appropriate quality systems (QS) in the health care organizations, in accordance with the international quality standards (ISO 9000 series etc). Such quality systems have been applied for a long time and very widely by the industry. It is a strong belief that the development of quality systems for health care would result in equal benefits as trusted in industry, in terms of efficiency and safety of health care services. For radiological practices, the quality systems are expected to become a framework for improving the optimization of practices and for maintaining good radiation safety, as well as providing a mechanism to prevent mistakes and accidents. In some countries, like the UK and The Netherlands, there are legal requirements to establish and maintain quality systems at certain type of radiological units. In some countries and some radiological units

  19. [Relevance of Vascular Trauma in Trauma Care - Impact on Clinical Course and Mortality].

    Science.gov (United States)

    Lech, L; Jerkku, T; Kanz, K-G; Wierer, M; Mutschler, W; Koeppel, T A; Lefering, R; Banafsche, R

    2016-10-01

    There is a lack of evidence as to the relevance of vascular trauma (VT) in patients with severe injuries. Therefore, we reviewed registry data in the present study in order to systematically objectify the effect of VT in these patients. This study aimed to provide an adequate picture of the relevance of vascular trauma and to identify adverse prognostic factors. In a retrospective analysis of records from the TraumaRegister DGU® (TR-DGU) in two subgroups with moderate and severe VT, we examined the records for differences in terms of morbidity, mortality, follow-up and prognostic parameters compared to patients without VT with the same ISS. From a total of 42,326 patients, 2,961 (7 %) had a VT, and in 2,437 cases a severe VT (AIS ≥ 3) was diagnosed (5.8 %). In addition to a higher incidence of shock and a 2 to 3-fold increase in fluid replacement and erythrocyte transfusion, patients with severe VT had a 60 % higher rate of multiple organ failure, and in-hospital mortality was twice as high (33.8 %). The massively increased early mortality (8.0 vs. 25.2 %) clearly illustrates how severely injured patients are placed at risk by the presence of a relevant VT with a comparable ISS. In our opinion, due to an unexpected poor prognosis in the TR-DGU data for vascular injuries, increased attention is required in the care of severely injured patients. Based on our comprehensive analysis of negative prognostic factors, a further adjustment to the standards of vascular medicine could be advisable. The influence of the level of care provided by the admitting hospital and the relevance of a further hospital transfer to prognosis and clinical outcome is currently being analysed. Georg Thieme Verlag KG Stuttgart · New York.

  20. A clinically relevant major cross-reactive allergen from mesquite tree pollen.

    Science.gov (United States)

    Dhyani, A; Singh, B P; Arora, N; Jain, V K; Sridhara, S

    2008-10-01

    Prosopis juliflora (mesquite) is one of the major sources of pollinosis in tropical and semi-arid countries of the world. The present study was undertaken to purify and characterize a major cross-reactive allergen from this tree species. Mesquite pollen extract was purified using reverse-phase chromatography. Allergen characterization was done by electrophoresis, enzyme-linked immunosorbent assay (ELISA) and Western blotting. Clinical relevance of the purified protein was analyzed by in vivo (skin tests) and in vitro experiments such as ELISA, histamine release, peripheral blood mononuclear cells (PBMC) proliferation and cytokine assays. Cross-reactivity of purified protein with allergenic tree species and lima bean (food) was assessed by inhibition assays. A 66-kDa protein was purified from mesquite pollen extract using octadecyl silica resin. Purified protein recognized 90% of mesquite-sensitized patients in skin test and ELISA. It induced significant histamine release in allergic patients' blood and interleukin-4 secretion in the PBMC culture supernatants. Inhibition assays suggested close allergenic relationship of this protein with Ailanthus excelsa, Cassia siamea, Salvadora persica pollen and Phaseolus lunatus (lima bean - an edible legume). A 66-kDa major cross-reactive allergen was isolated from mesquite pollen using single-step purification procedure. The protein seems relevant for clinical applications in allergic disorders.

  1. Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research

    Directory of Open Access Journals (Sweden)

    Hanson Janice L

    2012-11-01

    Full Text Available Abstract Background There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Methods Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. Results The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1 characteristics of quality in clinical notes, 2 desired elements within the clinical notes and 3 system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important

  2. Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research.

    Science.gov (United States)

    Hanson, Janice L; Stephens, Mark B; Pangaro, Louis N; Gimbel, Ronald W

    2012-11-19

    There are no empirically-grounded criteria or tools to define or benchmark the quality of outpatient clinical documentation. Outpatient clinical notes document care, communicate treatment plans and support patient safety, medical education, medico-legal investigations and reimbursement. Accurately describing and assessing quality of clinical documentation is a necessary improvement in an increasingly team-based healthcare delivery system. In this paper we describe the quality of outpatient clinical notes from the perspective of multiple stakeholders. Using purposeful sampling for maximum diversity, we conducted focus groups and individual interviews with clinicians, nursing and ancillary staff, patients, and healthcare administrators at six federal health care facilities between 2009 and 2011. All sessions were audio-recorded, transcribed and qualitatively analyzed using open, axial and selective coding. The 163 participants included 61 clinicians, 52 nurse/ancillary staff, 31 patients and 19 administrative staff. Three organizing themes emerged: 1) characteristics of quality in clinical notes, 2) desired elements within the clinical notes and 3) system supports to improve the quality of clinical notes. We identified 11 codes to describe characteristics of clinical notes, 20 codes to describe desired elements in quality clinical notes and 11 codes to describe clinical system elements that support quality when writing clinical notes. While there was substantial overlap between the aspects of quality described by the four stakeholder groups, only clinicians and administrators identified ease of translation into billing codes as an important characteristic of a quality note. Only patients rated prioritization of their medical problems as an aspect of quality. Nurses included care and education delivered to the patient, information added by the patient, interdisciplinary information, and infection alerts as important content. Perspectives of these four stakeholder

  3. Lower hybrid current drive at ITER-relevant high plasma densities

    International Nuclear Information System (INIS)

    Cesario, R.; Amicucci, L.; Cardinali, A.; Castaldo, C.; Marinucci, M.; Panaccione, L.; Pericoli-Ridolfini, V.; Tuccillo, A. A.; Tudisco, O.; Calabro, G.

    2009-01-01

    Recent experiments indicated that a further non-inductive current, besides bootstrap, should be necessary for developing advanced scenario for ITER. The lower hybrid current drive (LHCD) should provide such tool, but its effectiveness was still not proved in operations with ITER-relevant density of the plasma column periphery. Progress of the LH deposition modelling is presented, performed considering the wave physics of the edge, and different ITER-relevant edge parameters. Operations with relatively high edge electron temperatures are expected to reduce the LH || spectral broadening and, consequently, enabling the LH power to propagate also in high density plasmas ( || is the wavenumber component aligned to the confinement magnetic field). New results of FTU experiments are presented, performed by following the aforementioned modeling: they indicate that, for the first time, the LHCD conditions are established by operating at ITER-relevant high edge densities.

  4. The Role and Clinical Relevance of Disseminated Tumor Cells in Breast Cancer

    Directory of Open Access Journals (Sweden)

    Malgorzata Banys

    2014-01-01

    Full Text Available Tumor cell dissemination is a common phenomenon observed in most cancers of epithelial origin. One-third of breast cancer patients present with disseminated tumor cells (DTCs in bone marrow at time of diagnosis; these patients, as well as patients with persistent DTCs, have significantly worse clinical outcome than DTC-negative patients. Since DTC phenotype may differ from the primary tumor with regard to ER and HER2 status, reevaluation of predictive markers on DTCs may optimize treatment choices. In the present review, we report on the clinical relevance of DTC detection in breast cancer.

  5. Clinical relevance and scope of accidental extracoronary findings in coronary computed tomography angiography: A cardiac versus thoracic FOV study

    Energy Technology Data Exchange (ETDEWEB)

    Aglan, Iman; Jodocy, Daniel; Hiehs, Stefan; Soegner, Peter; Frank, Renate; Haberfellner, Berhard; Klauser, Andrea; Jaschke, Werner [Department of Radiology II, Innsbruck Medical University, Innsbruck (Austria); Feuchtner, Gudrun M. [Department of Radiology II, Innsbruck Medical University, Innsbruck (Austria)], E-mail: Gudrun.Feuchtner@i-med.ac.at

    2010-04-15

    Objective: To assess the spectrum and clinical relevance of extracoronary findings in coronary CT angiography (CCTA), and to compare a small (cardiac) field of view (FOV) to a large (thoracic) FOV setting. Material and methods: 1084 consecutive patients (mean 57 years) with low-to-intermediate risk of coronary artery disease were enrolled. 542 CCTA scans were interpreted with small FOV (160-190 mm{sup 2}) encompassing the cardiac region. In another 542 CCTA (patients matched for age and gender), read-out of an additional full FOV (>320 mm{sup 2}) covering the thorax was performed. Clinical relevance of extracoronary findings was considered as either 'significant' or 'non-significant'. 'Significant' findings were subclassified as either score 1: findings necessitating immediate therapeutic actions, or score 2: findings with undoubted clinical or prognostic relevance, requiring clinical awareness, follow-up or further investigations (non-urgent). 'Non-significant' findings were assigned to either score 3: findings not requiring follow-up or further tests, or as score 4: irrelevant incidental findings. Results: Significantly more patients with extracoronary findings were identified by using a full FOV with 43.2% (234/542) compared to a small FOV with 33.6% (182/542) (p = 0.001). Similarly, a higher total number of extracoronary findings (n = 394) was found on full FOV compared to small FOV (n = 250) (p < 0.001). The detection rate of clinically significant findings was higher by using full FOV compared to small FOV (25.6% versus 15.4%) (p < 0.001), out of those 2.2% versus 1.8% of findings required immediate actions (score 1), and 23.4% versus 13.6% (p = 0.0001), respectively were of clinical relevance (non-urgent, score 2). The rate of malign findings was 0.2%, and of acute pulmonary embolism 0.1%. More lung pathologies were observed by using full FOV compared to small FOV (22% versus 7%) (p < 0.0001), and the detection rate of

  6. The quality of veterinary in-clinic and reference laboratory biochemical testing.

    Science.gov (United States)

    Rishniw, Mark; Pion, Paul D; Maher, Tammy

    2012-03-01

    Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

  7. Prevalence of Potential and Clinically Relevant Statin-Drug Interactions in Frail and Robust Older Inpatients.

    Science.gov (United States)

    Thai, Michele; Hilmer, Sarah; Pearson, Sallie-Anne; Reeve, Emily; Gnjidic, Danijela

    2015-10-01

    A significant proportion of older people are prescribed statins and are also exposed to polypharmacy, placing them at increased risk of statin-drug interactions. To describe the prevalence rates of potential and clinically relevant statin-drug interactions in older inpatients according to frailty status. A cross-sectional study of patients aged ≥65 years who were prescribed a statin and were admitted to a teaching hospital between 30 July and 10 October 2014 in Sydney, Australia, was conducted. Data on socio-demographics, comorbidities and medications were collected using a standardized questionnaire. Potential statin-drug interactions were defined if listed in the Australian Medicines Handbook and three international drug information sources: the British National Formulary, Drug Interaction Facts and Drug-Reax(®). Clinically relevant statin-drug interactions were defined as interactions with the highest severity rating in at least two of the three international drug information sources. Frailty was assessed using the Reported Edmonton Frail Scale. A total of 180 participants were recruited (median age 78 years, interquartile range 14), 35.0% frail and 65.0% robust. Potential statin-drug interactions were identified in 10% of participants, 12.7% of frail participants and 8.5% of robust participants. Clinically relevant statin-drug interactions were identified in 7.8% of participants, 9.5% of frail participants and 6.8% of robust participants. Depending on the drug information source used, the prevalence rates of potential and clinically relevant statin-drug interactions ranged between 14.4 and 35.6% and between 14.4 and 20.6%, respectively. In our study of frail and robust older inpatients taking statins, the overall prevalence of potential statin-drug interactions was low and varied significantly according to the drug information source used.

  8. Locating relevant patient information in electronic health record data using representations of clinical concepts and database structures.

    Science.gov (United States)

    Pan, Xuequn; Cimino, James J

    2014-01-01

    Clinicians and clinical researchers often seek information in electronic health records (EHRs) that are relevant to some concept of interest, such as a disease or finding. The heterogeneous nature of EHRs can complicate retrieval, risking incomplete results. We frame this problem as the presence of two gaps: 1) a gap between clinical concepts and their representations in EHR data and 2) a gap between data representations and their locations within EHR data structures. We bridge these gaps with a knowledge structure that comprises relationships among clinical concepts (including concepts of interest and concepts that may be instantiated in EHR data) and relationships between clinical concepts and the database structures. We make use of available knowledge resources to develop a reproducible, scalable process for creating a knowledge base that can support automated query expansion from a clinical concept to all relevant EHR data.

  9. Resveratrol and Calcium Signaling: Molecular Mechanisms and Clinical Relevance

    Directory of Open Access Journals (Sweden)

    Audrey E. McCalley

    2014-06-01

    Full Text Available Resveratrol is a naturally occurring compound contributing to cellular defense mechanisms in plants. Its use as a nutritional component and/or supplement in a number of diseases, disorders, and syndromes such as chronic diseases of the central nervous system, cancer, inflammatory diseases, diabetes, and cardiovascular diseases has prompted great interest in the underlying molecular mechanisms of action. The present review focuses on resveratrol, specifically its isomer trans-resveratrol, and its effects on intracellular calcium signaling mechanisms. As resveratrol’s mechanisms of action are likely pleiotropic, its effects and interactions with key signaling proteins controlling cellular calcium homeostasis are reviewed and discussed. The clinical relevance of resveratrol’s actions on excitable cells, transformed or cancer cells, immune cells and retinal pigment epithelial cells are contrasted with a review of the molecular mechanisms affecting calcium signaling proteins on the plasma membrane, cytoplasm, endoplasmic reticulum, and mitochondria. The present review emphasizes the correlation between molecular mechanisms of action that have recently been identified for resveratrol and their clinical implications.

  10. [Relevance of drug use in clinical manifestations of schizophrenia].

    Science.gov (United States)

    Arias Horcajadas, F; Sánchez Romero, S; Padín Calo, J J

    2002-01-01

    To study the association between drugs use with schizophrenia clinical manifestations. The sample consists of 82 out-patients with schizophrenia, between 18 and 45 years old. They were evaluated with Addiction Severity Index (ASI) and with Positive and Negative Syndrome Scale (PANSS). A 6 months follow up was carried out. 37,8% patients had lifetime drug dependence (including alcohol and others drugs except for tobacco). The prevalence of dependence for the different drugs were: opioids 9,8%, cocaine 11%, alcohol 29,3%, cannabis 24,4%, tobacco 68,3%, caffeine 15,9%. Drug dependent had more family and legal problems. At the multiple regression analysis it was observed that cannabis and tobacco dependence was associated with a decrease in the PANSS negative symptoms subscale, and on the contrary, alcohol dependence produces a similar intensity increase at that scoring. We don't detect any clinical relevance effects over positive symptoms. Cannabis and tobacco may improve schizophrenia negative symptoms or neuroleptic secondary effects or patients with few negative symptoms may have more predisposition to the use, on the contrary alcohol use can impairment those symptoms.

  11. High-quality endoscope reprocessing decreases endoscope contamination.

    Science.gov (United States)

    Decristoforo, P; Kaltseis, J; Fritz, A; Edlinger, M; Posch, W; Wilflingseder, D; Lass-Flörl, C; Orth-Höller, D

    2018-02-24

    Several outbreaks of severe infections due to contamination of gastrointestinal (GI) endoscopes, mainly duodenoscopes, have been described. The rate of microbial endoscope contamination varies dramatically in literature. The aim of this multicentre prospective study was to evaluate the hygiene quality of endoscopes and automated endoscope reprocessors (AERs) in Tyrol/Austria. In 2015 and 2016, a total of 463 GI endoscopes and 105 AERs from 29 endoscopy centres were analysed by a routine (R) and a combined routine and advanced (CRA) sampling procedure and investigated for microbial contamination by culture-based and molecular-based analyses. The contamination rate of GI endoscopes was 1.3%-4.6% according to the national guideline, suggesting that 1.3-4.6 patients out of 100 could have had contacts with hygiene-relevant microorganisms through an endoscopic intervention. Comparison of R and CRA sampling showed 1.8% of R versus 4.6% of CRA failing the acceptance criteria in phase I and 1.3% of R versus 3.0% of CRA samples failing in phase II. The most commonly identified indicator organism was Pseudomonas spp., mainly Pseudomonas oleovorans. None of the tested viruses were detected in 40 samples. While AERs in phase I failed (n = 9, 17.6%) mainly due to technical faults, phase II revealed lapses (n = 6, 11.5%) only on account of microbial contamination of the last rinsing water, mainly with Pseudomonas spp. In the present study the contamination rate of endoscopes was low compared with results from other European countries, possibly due to the high quality of endoscope reprocessing, drying and storage. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  12. Sterol Composition of Clinically Relevant Mucorales and Changes Resulting from Posaconazole Treatment.

    Science.gov (United States)

    Müller, Christoph; Neugebauer, Thomas; Zill, Patrizia; Lass-Flörl, Cornelia; Bracher, Franz; Binder, Ulrike

    2018-05-19

    Mucorales are fungi with increasing importance in the clinics. Infections take a rapidly progressive course resulting in high mortality rates. The ergosterol biosynthesis pathway and sterol composition are of interest, since they are targeted by currently applied antifungal drugs. Nevertheless, Mucorales often exhibit resistance to these drugs, resulting in therapeutic failure. Here, sterol patterns of six clinically relevant Mucorales ( Lichtheimia corymbifera , Lichtheimia ramosa , Mucor circinelloides , Rhizomucor pusillus , Rhizopus arrhizus , and Rhizopus microsporus ) were analysed in a targeted metabolomics fashion after derivatization by gas chromatography-mass spectrometry. Additionally, the effect of posaconazole (POS) treatment on the sterol pattern of R. arrhizus was evaluated. Overall, fifteen different sterols were detected with species dependent variations in the total and relative sterol amount. Sterol analysis from R. arrhizus hyphae confronted with sublethal concentrations of posaconazole revealed the accumulation of 14-methylergosta-8,24-diene-3,6-diol, which is a toxic sterol that was previously only detected in yeasts. Sterol content and composition were further compared to the well-characterized pathogenic mold Aspergillus fumigatus . This work contributes to a better understanding of the ergosterol biosynthesis pathway of Mucorales, which is essential to improve antifungal efficacy, the identification of targets for novel drug design, and to investigate the combinatorial effects of drugs targeting this pathway.

  13. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed trials.

    Directory of Open Access Journals (Sweden)

    Melissa Paoloni

    Full Text Available Molecularly-guided trials (i.e. PMed now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting.A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77% successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days. Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type.Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week. Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer into the preclinical

  14. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

    Science.gov (United States)

    Moussa, Issam D; Klein, Lloyd W; Shah, Binita; Mehran, Roxana; Mack, Michael J; Brilakis, Emmanouil S; Reilly, John P; Zoghbi, Gilbert; Holper, Elizabeth; Stone, Gregg W

    2014-01-01

    Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment. Copyright © 2013 Wiley Periodicals, Inc.

  15. ChronQC: a quality control monitoring system for clinical next generation sequencing.

    Science.gov (United States)

    Tawari, Nilesh R; Seow, Justine Jia Wen; Perumal, Dharuman; Ow, Jack L; Ang, Shimin; Devasia, Arun George; Ng, Pauline C

    2018-05-15

    ChronQC is a quality control (QC) tracking system for clinical implementation of next-generation sequencing (NGS). ChronQC generates time series plots for various QC metrics to allow comparison of current runs to historical runs. ChronQC has multiple features for tracking QC data including Westgard rules for clinical validity, laboratory-defined thresholds and historical observations within a specified time period. Users can record their notes and corrective actions directly onto the plots for long-term recordkeeping. ChronQC facilitates regular monitoring of clinical NGS to enable adherence to high quality clinical standards. ChronQC is freely available on GitHub (https://github.com/nilesh-tawari/ChronQC), Docker (https://hub.docker.com/r/nileshtawari/chronqc/) and the Python Package Index. ChronQC is implemented in Python and runs on all common operating systems (Windows, Linux and Mac OS X). tawari.nilesh@gmail.com or pauline.c.ng@gmail.com. Supplementary data are available at Bioinformatics online.

  16. EXTRACELLULAR VESICLES: CLASSIFICATION, FUNCTIONS AND CLINICAL RELEVANCE

    Directory of Open Access Journals (Sweden)

    A. V. Oberemko

    2014-12-01

    Full Text Available This review presents a generalized definition of vesicles as bilayer extracellular organelles of all celular forms of life: not only eu-, but also prokaryotic. The structure and composition of extracellular vesicles, history of research, nomenclature, their impact on life processes in health and disease are discussed. Moreover, vesicles may be useful as clinical instruments for biomarkers, and they are promising as biotechnological drug. However, many questions in this area are still unresolved and need to be addressed in the future. The most interesting from the point of view of practical health care represents a direction to study the effect of exosomes and microvesicles in the development and progression of a particular disease, the possibility of adjusting the pathological process by means of extracellular vesicles of a particular type, acting as an active ingredient. Relevant is the further elucidation of the role and importance of exosomes to the surrounding cells, tissues and organs at the molecular level, the prospects for the use of non-cellular vesicles as biomarkers of disease.

  17. Clinical relevance of metronidazole and peripheral neuropathy: a systematic review of the literature.

    Science.gov (United States)

    Goolsby, Tiffany A; Jakeman, Bernadette; Gaynes, Robert P

    2018-03-01

    The objective of this paper was to review and evaluate the literature on metronidazole-associated peripheral neuropathy and determine the relevance in clinical practice. MEDLINE/PubMed, EBSCO, and Google Scholar were searched through February 2017 using the search terms metronidazole and peripheral neuropathy, or polyneuropathy, or paresthesia, or neurotoxicity. Relevant case reports, retrospective studies, surveys, and review articles were included. Bibliographies of all relevant articles were reviewed for additional sources. Overall, metronidazole is generally well tolerated, but serious neurotoxicity, including peripheral neuropathy, has been reported. The overall incidence of peripheral neuropathy associated with metronidazole is unknown. Our review found 36 case reports (40 unique patients) of metronidazole-associated peripheral neuropathy, with most cases (31/40) receiving a >42 g total (>4 weeks) of therapy. In addition, we reviewed 13 clinical studies and found varying rates of peripheral neuropathy from 0 to 50%. Within these clinical studies, we found a higher incidence of peripheral neuropathy in patients receiving >42 g total (>4 weeks) of metronidazole compared with those patients receiving ≤42 g total (17.9% vs. 1.7%). Nearly all patients had complete resolution of symptoms. In conclusion, peripheral neuropathy is rare in patients who receive ≤42 g total of metronidazole. Patients who receive higher total doses may be at higher risk of peripheral neuropathy, but symptoms resolve after discontinuation of therapy in most patients. Antimicrobial stewardship programs may consider use of antibiotic combinations that include metronidazole over broad-spectrum alternatives when treating with ≤42 g total of the drug (≤4 weeks). Published by Elsevier B.V.

  18. System for selecting relevant information for decision support.

    Science.gov (United States)

    Kalina, Jan; Seidl, Libor; Zvára, Karel; Grünfeldová, Hana; Slovák, Dalibor; Zvárová, Jana

    2013-01-01

    We implemented a prototype of a decision support system called SIR which has a form of a web-based classification service for diagnostic decision support. The system has the ability to select the most relevant variables and to learn a classification rule, which is guaranteed to be suitable also for high-dimensional measurements. The classification system can be useful for clinicians in primary care to support their decision-making tasks with relevant information extracted from any available clinical study. The implemented prototype was tested on a sample of patients in a cardiological study and performs an information extraction from a high-dimensional set containing both clinical and gene expression data.

  19. Analysis of quality data based on national clinical databases

    DEFF Research Database (Denmark)

    Utzon, Jan; Petri, A.L.; Christophersen, S.

    2009-01-01

    There is little agreement on the philosophy of measuring clinical quality in health care. How data should be analyzed and transformed to healthcare information is an ongoing discussion. To accept a difference in quality between health departments as a real difference, one should consider to which...... extent the selection of patients, random variation, confounding and inconsistency may have influenced results. The aim of this article is to summarize aspects of clinical healthcare data analyses provided from the national clinical quality databases and to show how data may be presented in a way which...... is understandable to readers without specialised knowledge of statistics Udgivelsesdato: 2009/9/14...

  20. Engaging clinical nurses in quality and performance improvement activities.

    Science.gov (United States)

    Albanese, Madeline P; Evans, Dietra A; Schantz, Cathy A; Bowen, Margaret; Disbot, Maureen; Moffa, Joseph S; Piesieski, Patricia; Polomano, Rosemary C

    2010-01-01

    Nursing performance measures are an integral part of quality initiatives in acute care; however, organizations face numerous challenges in developing infrastructures to support quality improvement processes and timely dissemination of outcomes data. At the Hospital of the University of Pennsylvania, a Magnet-designated organization, extensive work has been conducted to incorporate nursing-related outcomes in the organization's quality plan and to integrate roles for clinical nurses into the Department of Nursing and organization's core performance-based programs. Content and strategies that promote active involvement of nurses and prepare them to be competent and confident stakeholders in quality initiatives are presented. Engaging clinical nurses in the work of quality and performance improvement is essential to achieving excellence in clinical care. It is important to have structures and processes in place to bring meaningful data to the bedside; however, it is equally important to incorporate outcomes into practice. When nurses are educated about performance and quality measures, are engaged in identifying outcomes and collecting meaningful data, are active participants in disseminating quality reports, and are able to recognize the value of these activities, data become one with practice.

  1. The clinical relevance of sensitization to pollen-related fruits and vegetables in unselected pollen-sensitized adults

    DEFF Research Database (Denmark)

    Osterballe, M.; Hansen, T.K.; Mørtz, Charlotte G

    2005-01-01

    BACKGROUND: Previous studies have described cross-reactivity between fresh fruits, vegetables and pollen. However, no data demonstrates the clinical relevance of sensitization to pollen-related fruits and vegetables in unselected pollen-sensitized adults with and without symptoms in the pollen...... season. OBJECTIVE: The aim of this study was to estimate the clinical relevance of sensitization to pollen-related fruits and vegetables in unselected pollen-sensitized adults and to examine the diagnostic value of skin-prick test (SPT), histamine release and specific IgE compared with the outcome...... of oral challenge. METHODS: In total, 936 unselected adults (female : male 479 : 457, median age 33.7 years) were examined for pollen sensitization and clinical cross-reactivity with pollen-related fruits and vegetables by questionnaire, SPT, histamine release, specific IgE and oral challenge. RESULTS...

  2. [CAP quality management system in clinical laboratory and its issue].

    Science.gov (United States)

    Tazawa, Hiromitsu

    2004-03-01

    The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

  3. Impact of clinical registries on quality of patient care and clinical outcomes: A systematic review.

    Directory of Open Access Journals (Sweden)

    Dewan Md Emdadul Hoque

    Full Text Available Clinical quality registries (CQRs are playing an increasingly important role in improving health outcomes and reducing health care costs. CQRs are established with the purpose of monitoring quality of care, providing feedback, benchmarking performance, describing pattern of treatment, reducing variation and as a tool for conducting research.To synthesise the impact of clinical quality registries (CQRs as an 'intervention' on (I mortality/survival; (II measures of outcome that reflect a process or outcome of health care; (III health care utilisation; and (IV healthcare-related costs.The following electronic databases were searched: MEDLINE, EMBASE, CENTRAL, CINAHL and Google Scholar. In addition, a review of the grey literature and a reference check of citations and reference lists within articles was undertaken to identify relevant studies in English covering the period January 1980 to December 2016. The PRISMA-P methodology, checklist and standard search strategy using pre-defined inclusion and exclusion criteria and structured data extraction tools were used. Data on study design and methods, participant characteristics attributes of included registries and impact of the registry on outcome measures and/or processes of care were extracted.We identified 30102 abstracts from which 75 full text articles were assessed and finally 17 articles were selected for synthesis. Out of 17 studies, six focused on diabetes care, two on cardiac diseases, two on lung diseases and others on organ transplantations, rheumatoid arthritis, ulcer healing, surgical complications and kidney disease. The majority of studies were "before after" design (#11 followed by cohort design (#2, randomised controlled trial (#2, experimental non randomised study and one cross sectional comparison. The measures of impact of registries were multifarious and included change in processes of care, quality of care, treatment outcomes, adherence to guidelines and survival. Sixteen of 17

  4. A clinical decision support system algorithm for intravenous to oral antibiotic switch therapy: validity, clinical relevance and usefulness in a three-step evaluation study.

    Science.gov (United States)

    Akhloufi, H; Hulscher, M; van der Hoeven, C P; Prins, J M; van der Sijs, H; Melles, D C; Verbon, A

    2018-04-26

    To evaluate a clinical decision support system (CDSS) based on consensus-based intravenous to oral switch criteria, which identifies intravenous to oral switch candidates. A three-step evaluation study of a stand-alone CDSS with electronic health record interoperability was performed at the Erasmus University Medical Centre in the Netherlands. During the first step, we performed a technical validation. During the second step, we determined the sensitivity, specificity, negative predictive value and positive predictive value in a retrospective cohort of all hospitalized adult patients starting at least one therapeutic antibacterial drug between 1 and 16 May 2013. ICU, paediatric and psychiatric wards were excluded. During the last step the clinical relevance and usefulness was prospectively assessed by reports to infectious disease specialists. An alert was considered clinically relevant if antibiotics could be discontinued or switched to oral therapy at the time of the alert. During the first step, one technical error was found. The second step yielded a positive predictive value of 76.6% and a negative predictive value of 99.1%. The third step showed that alerts were clinically relevant in 53.5% of patients. For 43.4% it had already been decided to discontinue or switch the intravenous antibiotics by the treating physician. In 10.1%, the alert resulted in advice to change antibiotic policy and was considered useful. This prospective cohort study shows that the alerts were clinically relevant in >50% (n = 449) and useful in 10% (n = 85). The CDSS needs to be evaluated in hospitals with varying activity of infectious disease consultancy services as this probably influences usefulness.

  5. Quality of referral: What information should be included in a request for diagnostic imaging when a patient is referred to a clinical radiologist?

    Science.gov (United States)

    G Pitman, Alexander

    2017-06-01

    Referral to a clinical radiologist is the prime means of communication between the referrer and the radiologist. Current Australian and New Zealand government regulations do not prescribe what clinical information should be included in a referral. This work presents a qualitative compilation of clinical radiologist opinion, relevant professional recommendations, governmental regulatory positions and prior work on diagnostic error to synthesise recommendations on what clinical information should be included in a referral. Recommended requirements on what clinical information should be included in a referral to a clinical radiologist are as follows: an unambiguous referral; identity of the patient; identity of the referrer; and sufficient clinical detail to justify performance of the diagnostic imaging examination and to confirm appropriate choice of the examination and modality. Recommended guideline on the content of clinical detail clarifies when the information provided in a referral meets these requirements. High-quality information provided in a referral allows the clinical radiologist to ensure that exposure of patients to medical radiation is justified. It also minimises the incidence of perceptual and interpretational diagnostic error. Recommended requirements and guideline on the clinical detail to be provided in a referral to a clinical radiologist have been formulated for professional debate and adoption. © 2017 The Royal Australian and New Zealand College of Radiologists.

  6. Streptococcus pyogenes biofilms – formation, biology,and clinical relevance

    Directory of Open Access Journals (Sweden)

    Tomas eFiedler

    2015-02-01

    Full Text Available Streptococcus pyogenes (group A streptococci, GAS is an exclusive human bacterial pathogen. The virulence potential of this species is tremendous. Interactions with humans range from asymptomatic carriage over mild and superficial infections of skin and mucosal membranes up to systemic purulent toxic-invasive disease manifestations. Particularly the latter are a severe threat for predisposed patients and lead to significant death tolls worldwide. This places GAS among the most important Gram-positive bacterial pathogens. Many recent reviews have highlighted the GAS repertoire of virulence factors, regulators and regulatory circuits/networks that enable GAS to colonize the host and to deal with all levels of the host immune defense. This covers in vitro and in vivo studies, including animal infection studies based on mice and more relevant, macaque monkeys. It is now appreciated that GAS, like many other bacterial species, do not necessarily exclusively live in a planktonic lifestyle. GAS is capable of microcolony and biofilm formation on host cells and tissues. We are now beginning to understand that this feature significantly contributes to GAS pathogenesis. In this review we will discuss the current knowledge on GAS biofilm formation, the biofilm-phenotype associated virulence factors, regulatory aspects of biofilm formation, the clinical relevance, and finally contemporary treatment regimens and future treatment options.

  7. Evidence, Quality, and Waste: Solving the Value Equation in Neonatology.

    Science.gov (United States)

    Dukhovny, Dmitry; Pursley, DeWayne M; Kirpalani, Haresh M; Horbar, Jeffrey H; Zupancic, John A F

    2016-03-01

    Rising health care costs challenge governments, payers, and providers in delivering health care services. Tremendous pressures result to deliver better quality care while simultaneously reducing costs. This has led to a wholesale re-examination of current practice methods, including explicit consideration of efficiency and waste. Traditionally, reductions in the costs of care have been considered as independent, and sometimes even antithetical, to the practice of high-quality, intensive medicine. However, it is evident that provision of evidence-based, locally relevant care can result in improved outcomes, lower resource utilization, and opportunities to reallocate resources. This is particularly relevant to the practice of neonatology. In the United States, 12% of the annual birth cohort is affected by preterm birth, and 3% is affected by congenital anomalies. Both of these conditions are associated with costly health care during, and often long after, the NICU admission. We will discuss how 3 drivers of clinical practice in neonatal care (evidence-based medicine, evidence-based economics, and quality improvement) can together optimize clinical and fiscal outcomes. Copyright © 2016 by the American Academy of Pediatrics.

  8. Social Anxiety and Friendship Quality over Time.

    Science.gov (United States)

    Rodebaugh, Thomas L; Lim, Michelle H; Shumaker, Erik A; Levinson, Cheri A; Thompson, Tess

    2015-01-01

    High social anxiety in adults is associated with self-report of impaired friendship quality, but not necessarily with impairment reported by friends. Further, prospective prediction of social anxiety and friendship quality over time has not been tested among adults. We therefore examined friendship quality and social anxiety prospectively in 126 young adults (67 primary participants and 59 friends, aged 17-22 years); the primary participants were screened to be extreme groups to increase power and relevance to clinical samples (i.e., they were recruited based on having very high or very low social interaction anxiety). The prospective relationships between friendship quality and social anxiety were then tested using an Actor-Partner Interdependence Model. Friendship quality prospectively predicted social anxiety over time within each individual in the friendship, such that higher friendship quality at Time 1 predicted lower social anxiety approximately 6 months later at Time 2. Social anxiety did not predict friendship quality. Although the results support the view that social anxiety and friendship quality have an important causal relationship, the results run counter to the assumption that high social anxiety causes poor friendship quality. Interventions to increase friendship quality merit further consideration.

  9. Statistical significance versus clinical relevance.

    Science.gov (United States)

    van Rijn, Marieke H C; Bech, Anneke; Bouyer, Jean; van den Brand, Jan A J G

    2017-04-01

    In March this year, the American Statistical Association (ASA) posted a statement on the correct use of P-values, in response to a growing concern that the P-value is commonly misused and misinterpreted. We aim to translate these warnings given by the ASA into a language more easily understood by clinicians and researchers without a deep background in statistics. Moreover, we intend to illustrate the limitations of P-values, even when used and interpreted correctly, and bring more attention to the clinical relevance of study findings using two recently reported studies as examples. We argue that P-values are often misinterpreted. A common mistake is saying that P < 0.05 means that the null hypothesis is false, and P ≥0.05 means that the null hypothesis is true. The correct interpretation of a P-value of 0.05 is that if the null hypothesis were indeed true, a similar or more extreme result would occur 5% of the times upon repeating the study in a similar sample. In other words, the P-value informs about the likelihood of the data given the null hypothesis and not the other way around. A possible alternative related to the P-value is the confidence interval (CI). It provides more information on the magnitude of an effect and the imprecision with which that effect was estimated. However, there is no magic bullet to replace P-values and stop erroneous interpretation of scientific results. Scientists and readers alike should make themselves familiar with the correct, nuanced interpretation of statistical tests, P-values and CIs. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  10. Obtaining and Using Images in the Clinical Setting

    International Nuclear Information System (INIS)

    Cendales, Ricardo

    2009-01-01

    Currently small electronic devices capable of producing high quality images are available. The massive use of these devices has become common in the clinical setting as medical images represent a useful tool to document relevant clinical conditions for patient diagnosis, treatment and follow-up. Besides, clinical images are beneficial for legal, scientific and academic purposes. The extended practice without proper ethical guidelines might represent a significant risk for the protection of patient rights and clinical practice. This document discusses risks and duties when obtaining medical images, and presents some arguments on institutional and professional responsibilities around the definition of policies regarding the protection of privacy and dignity of the patient.

  11. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  12. Music's relevance for children with cancer: music therapists' qualitative clinical data-mining research.

    Science.gov (United States)

    O'Callaghan, Clare; Dun, Beth; Baron, Annette; Barry, Philippa

    2013-01-01

    Music is central in most children's lives. Understanding its relevance will advance efficacious pediatric supportive cancer care. Qualitative clinical data-mining uncovered four music therapists' perspectives about music and music therapy's relevance for pediatric oncology patients up to 14 years old. Inductive and comparative thematic analysis was performed on focus group transcripts and qualitative interrater reliability integrated. Music can offer children a safe haven for internalizing a healthy self-image alongside patient identity. Music therapy can calm, relieve distress, promote supportive relationships, enable self-care, and inspire playful creativity, associated with "normalcy" and hope. Preferred music and music therapy should be available in pediatric oncology.

  13. Cost-effective multiplexing before capture allows screening of 25 000 clinically relevant SNPs in childhood acute lymphoblastic leukemia

    DEFF Research Database (Denmark)

    Wesolowska, Agata; Dalgaard, M. D.; Borst, L.

    2011-01-01

    designed a cost-effective, high-throughput capture assay of â¼25â000 clinically relevant SNPs, and demonstrated that multiple samples can be tagged and pooled before genome capture in targeted enrichment with a sufficient sequencing depth for genotyping. This multiplexed, targeted sequencing method allows...... exploration of the impact of pharmacogenetics on efficacy and toxicity in childhood ALL treatment, which will be of importance for personalized chemotherapy.Leukemia advance online publication, 18 March 2011; doi:10.1038/leu.2011.32....

  14. Making the history of psychology clinically and philosophically relevant.

    Science.gov (United States)

    Vande Kemp, Hendrika

    2002-08-01

    The author discusses ways to make the history of psychology course relevant for a clinical psychology doctoral program within a multidenominational Protestant theological seminary. She uses a personalist orientation to emphasize the need to integrate psychology, philosophy, and theology. She differentiates among the intrapersonal, interpersonal, impersonal, and transpersonal dimensions of experience. She illustrates the rich multidisciplinary historical roots of contemporary psychology by tracing the the history of the term psychology and examining its meanings in the existential psychology of Søren Kierkegaard and in the 19th-century novel. She includes brief histories of the "new psychology" and of the unconscious. She describes how she uses the field of psychotheological integration to illustrate principles of historiography and summarizes resources used to supplement traditional textbooks.

  15. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

    Science.gov (United States)

    Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

    2013-01-15

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

  16. Effect of cisplatin on the clinically relevant radiosensitivity of human cervical carcinoma cell lines

    International Nuclear Information System (INIS)

    Britten, Richard A.; Evans, Andrew J.; Allalunis-Turner, M. Joan; Pearcey, Robert G.

    1996-01-01

    Purpose: To evaluate the effect of clinically relevant levels of cisplatin on the radiosensitivity of human cervical tumor cells, and to estimate what changes in local control rates might be expected to accrue from the concomitant use of cisplatin during fractionated radiotherapy. Methods and Materials: The effects of concomitant cisplatin (1 μg/ml, a typical intratumor concentration) on the clinically relevant radiosensitivity, i.e., surviving fraction after 2 G (SF 2 ) values, was determined in 19 cloned human cervical tumor cell lines. These early passage cell lines had SF 2 values ranging from 0.26 to 0.87. Results: The concomitant administration of cisplatin reduced the clinically relevant radiosensitivity in the majority (11 out of 19) of the human tumor cell lines investigated. In only 4 out of 19 was any radiosensitization observed, and in 4 out of 19 cell lines there was no significant change in radiosensitivity. However, the sum of the independent cell killing by radiation and cisplatin, was approximately twofold higher than after radiation alone. There was no apparent dependence of the cisplatin-induced changes in SF 2 values upon the level of cell killing by cisplatin. However, there is a suggestion that concomitant cisplatin administration may have a differential effect in inherently radiosensitive and resistant human tumor cell lines. Conclusions: Our data suggest that concomitant cisplatin/radiotherapy regimens may result in a higher level of local tumor control, but primarily through additive toxicity and not through radiosensitization. Future improvements in local tumor control may, thus, be derived by increasing the total dose of cisplatin

  17. Clinical Relevance of Gene Copy Number Variation in Metastatic Clear Cell Renal Cell Carcinoma.

    Science.gov (United States)

    Nouhaud, François-Xavier; Blanchard, France; Sesboue, Richard; Flaman, Jean-Michel; Sabourin, Jean-Christophe; Pfister, Christian; Di Fiore, Frédéric

    2018-02-23

    Gene copy number variations (CNVs) have been reported to be frequent in renal cell carcinoma (RCC), with potential prognostic value for some. However, their clinical utility, especially to guide treatment of metastatic disease remains to be established. Our objectives were to assess CNVs on a panel of selected genes and determine their clinical relevance in patients who underwent treatment of metastatic RCC. The genetic assessment was performed on frozen tissue samples of clear cell metastatic RCC using quantitative multiplex polymerase chain reaction of short fluorescent fragment method to detect CNVs on a panel of 14 genes of interest. The comparison of the electropherogram obtained from both tumor and normal renal adjacent tissue allowed for CNV identification. The clinical, biologic, and survival characteristics were assessed for their associations with the most frequent CNVs. Fifty patients with clear cell metastatic RCC were included. The CNV rate was 21.4%. The loss of CDKN2A and PLG was associated with a higher tumor stage (P relevance, especially those located on CDKN2A, PLG, and ALDOB, in a homogeneous cohort of patients with clear cell metastatic RCC. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Clinical relevance of surgical site infection as defined by the criteria of the Centers for Disease Control and Prevention

    DEFF Research Database (Denmark)

    Henriksen, N A; Meyhoff, C S; Wetterslev, J

    2010-01-01

    Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant (C...... a suitable standard definition for monitoring and identifying SSI, even if some cases of less clinically significant superficial SSI are included.......Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant...... hospital stay or referral to an intensive care unit for SSI. The rate of CRSSI was 38 of 54 (70%) in patients with CDC-diagnosed SSI and none in patients without a CDC-diagnosed SSI. Sixty-one percent of the CDC-diagnosed SSIs were superficial, of which 48% were considered clinically relevant...

  19. An institutional review board-based clinical research quality assurance program.

    Science.gov (United States)

    Lad, Pramod M; Dahl, Rebecca

    2013-01-01

    Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

  20. [Effectiveness of an educational program for respiratory rehabilitation of Chronic Obstructive Pulmonary Disease patients in Primary Care in improving the quality of life, symptoms, and clinical risk].

    Science.gov (United States)

    Blánquez Moreno, Cristina; Colungo Francia, Cristina; Alvira Balada, M Carme; Kostov, Belchin; González-de Paz, Luis; Sisó-Almirall, Antoni

    2017-10-04

    To determine the impact of an educational program to improve the management of chronic obstructive pulmonary disease (COPD) that contributes to an increase of the quality of life, exercise capacity, level of dyspnoea, and clinical risk. Intervention study without controls. Primary Healthcare Centre. 193 patients with COPD were invited, 73 accepted and 55 participated in the educational program. Respiratory rehabilitation educational program with basic concepts of pulmonary and respiratory pathophysiology, respiratory physiotherapy exercises, practical workshop on the use of the most frequent inhalation devices, understanding of chronic disease and self-care measures in case of exacerbation. The quality of life (the COPD assessment test), exercise tolerance (the Six-Minute Walk Test), rating of perceived exertion (Borg Dyspnoea Score) and clinical risk (BODE index) were assessed by means of validated questionnaires in Spanish. A total of 43 (78.2%) participants completed the program. An improvement in the quality of life by a mean of 3.3 points was observed (95%CI; 1.76-4.84). Just over half (53.5%) of the participants obtained a clinically relevant improvement. Participants also improved their physical exercise capacity at post-intervention by increasing the distance that they walked in 6min by a mean of 20.76m (95%CI; 2.57-38.95). Improvements in the level of dyspnoea and clinical risk were also observed. The educational program shows a statistically significant and clinically relevant improvement in the quality of life, fatigue, symptomatology, exercise capacity, level of dyspnoea, and clinical risk. The program is adaptable to the health care routine of healthcare centres. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  1. The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

    Directory of Open Access Journals (Sweden)

    Stephan Brenner

    Full Text Available A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs, a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC, the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example.We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi.Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks.The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining

  2. The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

    Science.gov (United States)

    Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S

    2015-01-01

    A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining MNH program

  3. A systematic review on the effect of sweeteners on glycemic response and clinically relevant outcomes

    Directory of Open Access Journals (Sweden)

    Wiebe Natasha

    2011-11-01

    Full Text Available Abstract Background The major metabolic complications of obesity and type 2 diabetes may be prevented and managed with dietary modification. The use of sweeteners that provide little or no calories may help to achieve this objective. Methods We did a systematic review and network meta-analysis of the comparative effectiveness of sweetener additives using Bayesian techniques. MEDLINE, EMBASE, CENTRAL and CAB Global were searched to January 2011. Randomized trials comparing sweeteners in obese, diabetic, and healthy populations were selected. Outcomes of interest included weight change, energy intake, lipids, glycated hemoglobin, markers of insulin resistance and glycemic response. Evidence-based items potentially indicating risk of bias were assessed. Results Of 3,666 citations, we identified 53 eligible randomized controlled trials with 1,126 participants. In diabetic participants, fructose reduced 2-hour blood glucose concentrations by 4.81 mmol/L (95% CI 3.29, 6.34 compared to glucose. Two-hour blood glucose concentration data comparing hypocaloric sweeteners to sucrose or high fructose corn syrup were inconclusive. Based on two ≤10-week trials, we found that non-caloric sweeteners reduced energy intake compared to the sucrose groups by approximately 250-500 kcal/day (95% CI 153, 806. One trial found that participants in the non-caloric sweetener group had a decrease in body mass index compared to an increase in body mass index in the sucrose group (-0.40 vs 0.50 kg/m2, and -1.00 vs 1.60 kg/m2, respectively. No randomized controlled trials showed that high fructose corn syrup or fructose increased levels of cholesterol relative to other sweeteners. Conclusions Considering the public health importance of obesity and its consequences; the clearly relevant role of diet in the pathogenesis and maintenance of obesity; and the billions of dollars spent on non-caloric sweeteners, little high-quality clinical research has been done. Studies are

  4. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study.

    Science.gov (United States)

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes.

  5. Online drug databases: a new method to assess and compare inclusion of clinically relevant information.

    Science.gov (United States)

    Silva, Cristina; Fresco, Paula; Monteiro, Joaquim; Rama, Ana Cristina Ribeiro

    2013-08-01

    Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB. To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use. Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created. A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed

  6. Retrieving clinically relevant diabetic retinopathy images using a multi-class multiple-instance framework

    Science.gov (United States)

    Chandakkar, Parag S.; Venkatesan, Ragav; Li, Baoxin

    2013-02-01

    Diabetic retinopathy (DR) is a vision-threatening complication from diabetes mellitus, a medical condition that is rising globally. Unfortunately, many patients are unaware of this complication because of absence of symptoms. Regular screening of DR is necessary to detect the condition for timely treatment. Content-based image retrieval, using archived and diagnosed fundus (retinal) camera DR images can improve screening efficiency of DR. This content-based image retrieval study focuses on two DR clinical findings, microaneurysm and neovascularization, which are clinical signs of non-proliferative and proliferative diabetic retinopathy. The authors propose a multi-class multiple-instance image retrieval framework which deploys a modified color correlogram and statistics of steerable Gaussian Filter responses, for retrieving clinically relevant images from a database of DR fundus image database.

  7. Evaluating clinical librarian services: a systematic review.

    Science.gov (United States)

    Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

    2011-03-01

      Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

  8. Achieving quality assurance through clinical audit.

    Science.gov (United States)

    Patel, Seraphim

    2010-06-01

    Audit is a crucial component of improvements to the quality of patient care. Clinical audits are undertaken to help ensure that patients can be given safe, reliable and dignified care, and to encourage them to self-direct their recovery. Such audits are undertaken also to help reduce lengths of patient stay in hospital, readmission rates and delays in discharge. This article describes the stages of clinical audit and the support required to achieve organisational core values.

  9. Clinically relevant risk factors for suicide: Comparison between clinical group with passive suicidal ideation, active suicidal ideation and without suicidal ideation

    OpenAIRE

    Miloseva, Lence; Cuijpers, Pim; Stojcev, Saso; Niklewski, Gunter; Richter, Kneginja; Jovevska, Svetlana; Arsova, Roza; Serafimov, Aleksandar

    2015-01-01

    Introduction: In recent years, researchers and clinicians do not treat passive suicidal ideation as a clinically relevant risk factor for suicide, while underestimating the strength of this desire to die, compared with making a plan for suicide in individuals having active suicidal ideation. This research study is clinically prospective, cross-sequential, but also partly retrospective because it involves also variables from the past, such as patients’ history data (number of suicidal attempts...

  10. Effective interventions on service quality improvement in a physiotherapy clinic.

    Science.gov (United States)

    Gharibi, Farid; Tabrizi, JafarSadegh; Eteraf Oskouei, MirAli; AsghariJafarabadi, Mohammad

    2014-01-01

    Service quality is considered as a main domain of quality associ-ated with non-clinical aspect of healthcare. This study aimed to survey and im-proves service quality of delivered care in the Physiotherapy Clinic affiliated with the Tabriz University of Medical Sciences, Tabriz, Iran. A quasi experimental interventional study was conducted in the Physiotherapy Clinic, 2010-2011. Data were collected using a validated and reli-able researcher made questionnaire with participation of 324 patients and their coadjutors. The study questionnaire consisted of 7 questions about demographic factors and 38 questions for eleven aspects of service quality. Data were then analyzed using paired samples t-test by SPSS16. In the pre intervention phase, six aspects of service quality including choice of provider, safety, prevention and early detection, dignity, autonomy and availability achieved non-acceptable scores. Following interventions, all aspects of the service quality improved and also total service quality score improved from 8.58 to 9.83 (PService quality can be improved by problem implementation of appropriate interventions. The acquired results can be used in health system fields to create respectful environments for healthcare customers.

  11. Clinically relevant magnetic resonance imaging (MRI findings in elite swimmers’ shoulders

    Directory of Open Access Journals (Sweden)

    Arno Celliers

    2017-01-01

    Objective: To assess clinically relevant MRI findings in the shoulders of symptomatic and asymptomatic elite swimmers. Method: Twenty (aged 16–23 years elite swimmers completed questionnaires on their swimming training, pain and shoulder function. MRI of both shoulders (n = 40 were performed and all swimmers were given a standardised clinical shoulder examination. Results: Both shoulders of 11 male and 9 female elite swimmers (n = 40 were examined. Eleven of the 40 shoulders were clinically symptomatic and 29 were asymptomatic. The most common clinical finding in both the symptomatic and asymptomatic shoulders was impingement during internal rotation, with impingement in 54.5% of the symptomatic shoulders and in 31.0% of the asymptomatic shoulders. The most common MRI findings in the symptomatic and asymptomatic shoulders were supraspinatus tendinosis (45.5% vs. 20.7%, subacromial subdeltoid fluid (45.5% vs. 34.5%, increased signal in the AC Joint (45.5% vs. 37.9% and AC joint arthrosis (36.4% vs. 34.5%. Thirty-nine (97.5% of the shoulders showed abnormal MRI features. Conclusion: MRI findings in the symptomatic and asymptomatic shoulders of young elite swimmers are similar and care should be taken when reporting shoulder MRIs in these athletes. Asymptomatic shoulders demonstrate manifold MRI abnormalities that may be radiologically significant but appear not to be clinically significant.

  12. Demographic, clinical, and quality of life variables related to embarrassment in veterans living with an intestinal stoma.

    Science.gov (United States)

    Mitchell, Kimberly A; Rawl, Susan M; Schmidt, C Max; Grant, Marcia; Ko, Clifford Y; Baldwin, Carol M; Wendel, Christopher; Krouse, Robert S

    2007-01-01

    The study aims were to identify demographic, clinical, and quality of life variables related to embarrassment for people living with ostomies and to determine the experiences and/or feelings of veterans who were embarrassed by their ostomy. This was a cross-sectional, correlational study. A convenience sample of veterans (n = 239) living with ostomies from 3 VA medical centers was studied. The veterans were primarily Caucasian (84%), male (92%), and older (M = 69). The modified City of Hope Quality of Life-Ostomy questionnaire was used. Additionally, an open-ended question related to living with an ostomy was asked. The questionnaire packets were mailed to participants and self-administered. Approximately half of the participants (48%) rated their embarrassment as low, but 26% reported high embarrassment. Participants with high embarrassment were compared to those with low embarrassment on demographic, clinical, and quality of life variables. High embarrassment was associated with poorer total quality of life (P hopefulness were associated with low embarrassment (P < .001). Sources of embarrassment included leakage, odor, and noise. Embarrassment may negatively impact a person's quality of life; therefore, the variables associated with high embarrassment should be recognized and addressed.

  13. Does quality improvement work in neonatology improve clinical outcomes?

    Science.gov (United States)

    Ellsbury, Dan L; Clark, Reese H

    2017-04-01

    Quality improvement initiatives in neonatology have been promoted as an important way of improving outcomes of newborns. The purpose of this review is to examine the effectiveness of recent quality improvement work in improving the outcomes of infants requiring neonatal intensive care. Quality improvement collaboratives and single-center projects demonstrate improvement of clinical processes and outcomes in neonatology that impact both preterm and term infants. Declines in morbidities, resource use, and length of stay have been associated with reductions in healthcare costs. Recent quality improvement work has shown evidence of improvement in clinical outcomes in neonatal intensive care patients. These improvements have important implications for the reduction of healthcare costs in this population.

  14. Psychological, Relational, and Biological Correlates of Ego-Dystonic Masturbation in a Clinical Setting

    Directory of Open Access Journals (Sweden)

    Giovanni Castellini, PhD, MD

    2016-09-01

    Conclusion: Clinicians should consider that some subjects seeking treatment in a sexual medicine setting might report compulsive sexual behaviors. EM represents a clinically relevant cause of disability, given the high level of psychological distress reported by subjects with this condition, and the severe impact on quality of life in interpersonal relationships.

  15. [Enduring relevance. An introduction to the clinical contributions of K. R. Eissler].

    Science.gov (United States)

    Garcia, Emanuel E

    2007-01-01

    The author offers a personal selection and discussion of papers that epitomize the enduring relevance of Eissler's contributions to psychoanalytic therapy. The innovations of technique embodied by these works (on parameters, schizophrenia, adolescence, cure, fees, and the treatment of the dying patient) reveal a therapeutic approach that is a natural extension of psychoanalytic science: patient-centered, maximally comprehensive and appropriately flexible. Firsthand observations of Eissler's clinical manner and a selected bibliography are also presented.

  16. Professional Quality of Life and Clinical Competencies among Korean Nurses

    Directory of Open Access Journals (Sweden)

    Kyunghee Kim, PhD

    2015-09-01

    Conclusions: This study demonstrated that it is possible to directly examine the relationship between professional quality of life level and clinical competence among nurses. Thus, interventions to increase nurses' compassion satisfaction and relieve compassion fatigue are needed, as professional quality of life may affect clinical competence.

  17. Quality assurance in clinical trials : a multi-disciplinary approach

    International Nuclear Information System (INIS)

    Cornes, D.

    2001-01-01

    Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  18. Does transcutaneous electrical nerve stimulation (TENS have a clinically relevant analgesic effect on different pain conditions? A literature review

    Directory of Open Access Journals (Sweden)

    Asami Naka

    2013-07-01

    Full Text Available Transcutaneous electric nerve stimulation (TENS is a standard therapy used in different painful conditions such as low back pain, diabetic polyneuropathy or arthrosis. However, literature reviews focusing on the effects and the clinical implication of this method in various painful conditions are yet scarce. The purpose of this literature research was to determine, whether TENS provides an analgesic effect on common painful conditions in clinical practice. Literature research was performed using three data bases (Pubmed, Embase, Cochrane Database, focusing on papers published in the space of time from 2007 to 2012. Papers were evaluated from two reviewers independently concerning the clinical outcome, taking account for the level of external evidence according to the German Cochrane levels of evidence (Ia – IV. 133 papers of varying methodological quality dealing with different painful conditions were selected in total. A clinically relevant analgesic effect was described in 90 painful conditions (67%. In 30 painful states (22%, the outcome was inconclusive due to the study design. No significant analgesic effect of TENS was observed in 15 painful conditions (11%. The vast majority of the papers were classified as Cochrane evidence level Ib (n = 64; 48%, followed by level Ia (n = 23; 17%, level III (n = 18; 14%, level IV (n = 15; 11%, level IIb (n = 10; 8% and level IIa (n = 3; 2%. Most of the studies revealed an analgesic effect in various painful conditions, confirming the usefulness of TENS in clinical practice.

  19. Availability, quality and relevance of toxicogenomics data for human health risk assessment: A scoping review of the literature on trihalomethanes.

    Science.gov (United States)

    Vachon, Julien; Pagé-Larivière, Florence; Sirard, Marc-André; Rodriguez, Manuel J; Levallois, Patrick; Campagna, Céline

    2018-03-05

    Human health risk assessment (HHRA) must be adapted to the challenges of the 21st century, and the use of toxicogenomics data in HHRA is among the changes that regulatory agencies worldwide are trying to implement. However, the use of toxicogenomics data in HHRA is still limited. The purpose of this study was to explore the availability, quality and relevance to HHRA of toxicogenomics publications as potential barriers to their use in HHRA. We conducted a scoping review of available toxicogenomics literature, using trihalomethanes as a case study. Four bibliographic databases (including the Comparative Toxicogenomics Database) were assessed. An evaluation table was developed to characterise quality and relevance of studies included on the basis of criteria proposed in the literature. Studies were selected and analysed by two independent reviewers. Only nine studies, published between 1997 and 2015, were included in the analysis. Based on the selected criteria, critical methodological details were often missing; in fact, only three out of nine studies were considered to be of adequate quality for HHRA. No studies met more than three (out of seven) criteria of relevance to HHRA (e.g. adequate number of doses and sample size, etc.). This first scoping review of toxicogenomics publications on trihalomethanes shows that low availability, quality and relevance to HHRA of toxicogenomics publications presents potential barriers to their use in HHRA. Improved reporting of methodological details and study design is needed in the future so that toxicogenomics studies can be appropriately assessed regarding their quality and value for HHRA.

  20. Assessing data quality and the variability of source data verification auditing methods in clinical research settings.

    Science.gov (United States)

    Houston, Lauren; Probst, Yasmine; Martin, Allison

    2018-05-18

    Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings. Copyright © 2018. Published by Elsevier Inc.

  1. Diabetes quality management in care groups and outpatient clinics

    NARCIS (Netherlands)

    Campmans-Kuijpers, M.J.E.

    2015-01-01

    This research project relates to diabetes quality management in Dutch care groups (40-200 GP practices) and outpatient clinics. Improvement of quality management at an organisational level on top of the existing quality management in separate general practices is expected to be associated with

  2. Development of a new microtiter plate format for clinically relevant assays.

    Science.gov (United States)

    Piletska, Elena V; Piletsky, Stanislav S; Whitcombe, Michael J; Chianella, Iva; Piletsky, Sergey A

    2012-02-21

    A new format for the microtiter plate-based assays was proposed. The novelty involves the use of disk-shaped inserts for immobilization of biological and chemical reagents. The internal opening of the disks allows measurements of the reactions by standard microtiter plate readers without any additional steps involving liquid handling. Ideally the plate end-users just have to add the sample and take the measurement without any need of multiple reagent additions or transfer of the liquid to a different plate. The novel assay format also allows handling of reagents which are not soluble in an aqueous environment. As a proof of concept we describe here several model reactions which are compatible with microtiter plate format, such as monitoring enzymatic reactions catalyzed by glucose oxidase (GOx) and urease, measurements of proteins by BCA assay, analysis of pH, and concentration of antioxidants. The "mix and match" approach in the disk-shape format allows multiplexing and could be particularly useful for high throughput screening. One of the potential application areas for this novel assay format could be in a multianalyte system for measurement of clinically relevant analytes in primary care.

  3. QNOTE: an instrument for measuring the quality of EHR clinical notes.

    Science.gov (United States)

    Burke, Harry B; Hoang, Albert; Becher, Dorothy; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; Sessums, Laura L; O'Malley, Patrick; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

    2014-01-01

    The outpatient clinical note documents the clinician's information collection, problem assessment, and patient management, yet there is currently no validated instrument to measure the quality of the electronic clinical note. This study evaluated the validity of the QNOTE instrument, which assesses 12 elements in the clinical note, for measuring the quality of clinical notes. It also compared its performance with a global instrument that assesses the clinical note as a whole. Retrospective multicenter blinded study of the clinical notes of 100 outpatients with type 2 diabetes mellitus who had been seen in clinic on at least three occasions. The 300 notes were rated by eight general internal medicine and eight family medicine practicing physicians. The QNOTE instrument scored the quality of the note as the sum of a set of 12 note element scores, and its inter-rater agreement was measured by the intraclass correlation coefficient. The Global instrument scored the note in its entirety, and its inter-rater agreement was measured by the Fleiss κ. The overall QNOTE inter-rater agreement was 0.82 (CI 0.80 to 0.84), and its note quality score was 65 (CI 64 to 66). The Global inter-rater agreement was 0.24 (CI 0.19 to 0.29), and its note quality score was 52 (CI 49 to 55). The QNOTE quality scores were consistent, and the overall QNOTE score was significantly higher than the overall Global score (p=0.04). We found the QNOTE to be a valid instrument for evaluating the quality of electronic clinical notes, and its performance was superior to that of the Global instrument. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  4. Implementing clinical governance in English primary care groups/trusts: reconciling quality improvement and quality assurance.

    Science.gov (United States)

    Campbell, S M; Sheaff, R; Sibbald, B; Marshall, M N; Pickard, S; Gask, L; Halliwell, S; Rogers, A; Roland, M O

    2002-03-01

    To investigate the concept of clinical governance being advocated by primary care groups/trusts (PCG/Ts), approaches being used to implement clinical governance, and potential barriers to its successful implementation in primary care. Qualitative case studies using semi-structured interviews and documentation review. Twelve purposively sampled PCG/Ts in England. Fifty senior staff including chief executives, clinical governance leads, mental health leads, and lay board members. Participants' perceptions of the role of clinical governance in PCG/Ts. PCG/Ts recognise that the successful implementation of clinical governance in general practice will require cultural as well as organisational changes, and the support of practices. They are focusing their energies on supporting practices and getting them involved in quality improvement activities. These activities include, but move beyond, conventional approaches to quality assessment (audit, incentives) to incorporate approaches which emphasise corporate and shared learning. PCG/Ts are also engaged in setting up systems for monitoring quality and for dealing with poor performance. Barriers include structural barriers (weak contractual levers to influence general practices), resource barriers (perceived lack of staff or money), and cultural barriers (suspicion by practice staff or problems overcoming the perceived blame culture associated with quality assessment). PCG/Ts are focusing on setting up systems for implementing clinical governance which seek to emphasise developmental and supportive approaches which will engage health professionals. Progress is intentionally incremental but formidable challenges lie ahead, not least reconciling the dual role of supporting practices while monitoring (and dealing with poor) performance.

  5. A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

    Science.gov (United States)

    Aboushanab, Tamer; AlSanad, Saud

    2018-06-08

    Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

  6. Automatic quality control in clinical (1)H MRSI of brain cancer.

    Science.gov (United States)

    Pedrosa de Barros, Nuno; McKinley, Richard; Knecht, Urspeter; Wiest, Roland; Slotboom, Johannes

    2016-05-01

    MRSI grids frequently show spectra with poor quality, mainly because of the high sensitivity of MRS to field inhomogeneities. These poor quality spectra are prone to quantification and/or interpretation errors that can have a significant impact on the clinical use of spectroscopic data. Therefore, quality control of the spectra should always precede their clinical use. When performed manually, quality assessment of MRSI spectra is not only a tedious and time-consuming task, but is also affected by human subjectivity. Consequently, automatic, fast and reliable methods for spectral quality assessment are of utmost interest. In this article, we present a new random forest-based method for automatic quality assessment of (1)H MRSI brain spectra, which uses a new set of MRS signal features. The random forest classifier was trained on spectra from 40 MRSI grids that were classified as acceptable or non-acceptable by two expert spectroscopists. To account for the effects of intra-rater reliability, each spectrum was rated for quality three times by each rater. The automatic method classified these spectra with an area under the curve (AUC) of 0.976. Furthermore, in the subset of spectra containing only the cases that were classified every time in the same way by the spectroscopists, an AUC of 0.998 was obtained. Feature importance for the classification was also evaluated. Frequency domain skewness and kurtosis, as well as time domain signal-to-noise ratios (SNRs) in the ranges 50-75 ms and 75-100 ms, were the most important features. Given that the method is able to assess a whole MRSI grid faster than a spectroscopist (approximately 3 s versus approximately 3 min), and without loss of accuracy (agreement between classifier trained with just one session and any of the other labelling sessions, 89.88%; agreement between any two labelling sessions, 89.03%), the authors suggest its implementation in the clinical routine. The method presented in this article was implemented

  7. Clinical relevance of comorbidity in anxiety disorders : A report from the Netherlands Study of Depression and Anxiety (NESDA)

    NARCIS (Netherlands)

    Hofmeijer-Sevink, Mieke Klein; Batelaan, Neeltje M.; van Megen, Harold J. G. M.; Penninx, Brenda W.; Cath, Danielle C.; van den Hout, Marcel A.; van Balkom, Anton J. L. M.

    Background: To study the clinical relevance of type of comorbidity and number of comorbid disorders in anxiety disorders. Four groups were compared according to sociodemographic-, vulnerability- and clinical factors: single anxiety disorder, anxiety-anxiety comorbidity, anxiety-depressive

  8. Clinical relevance of comorbidity in anxiety disorders: A report from the Netherlands Study of Depression and Anxiety (NESDA)

    NARCIS (Netherlands)

    Klein Hofmeijer-Sevink, M.; Batelaan, N.M.; van Megen, H.J.G.M.; Penninx, B.W.J.H.; Cath, D.C.; van Hout, M.A.; van Balkom, A.J.L.M.

    2012-01-01

    Background: To study the clinical relevance of type of comorbidity and number of comorbid disorders in anxiety disorders. Four groups were compared according to sociodemographic-, vulnerability- and clinical factors: single anxiety disorder, anxiety-anxiety comorbidity, anxiety-depressive

  9. Improved quality monitoring of multi-center acupuncture clinical trials in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2009-12-01

    Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

  10. The quality of travel clinics in the Netherlands

    NARCIS (Netherlands)

    Moerland, Wendy; Koeman, Susan C.; van den Hoek, Anneke; Warris-Versteegen, Anita A.; Inspector, Health; Overbosch, David; Sonder, Gerard J. B.

    2006-01-01

    In 1996, the Dutch National Coordination Center for Travelers' Health Advice (LCR) was established to improve uniformity in health advice to travelers and in the quality of national vaccination centers. In this study, we evaluate the influence of LCR guidelines on the quality of travel clinics in

  11. Decision Analysis for Metric Selection on a Clinical Quality Scorecard.

    Science.gov (United States)

    Guth, Rebecca M; Storey, Patricia E; Vitale, Michael; Markan-Aurora, Sumita; Gordon, Randolph; Prevost, Traci Q; Dunagan, Wm Claiborne; Woeltje, Keith F

    2016-09-01

    Clinical quality scorecards are used by health care institutions to monitor clinical performance and drive quality improvement. Because of the rapid proliferation of quality metrics in health care, BJC HealthCare found it increasingly difficult to select the most impactful scorecard metrics while still monitoring metrics for regulatory purposes. A 7-step measure selection process was implemented incorporating Kepner-Tregoe Decision Analysis, which is a systematic process that considers key criteria that must be satisfied in order to make the best decision. The decision analysis process evaluates what metrics will most appropriately fulfill these criteria, as well as identifies potential risks associated with a particular metric in order to identify threats to its implementation. Using this process, a list of 750 potential metrics was narrowed to 25 that were selected for scorecard inclusion. This decision analysis process created a more transparent, reproducible approach for selecting quality metrics for clinical quality scorecards. © The Author(s) 2015.

  12. Diabetes quality management in Dutch care groups and outpatient clinics: a cross-sectional study.

    Science.gov (United States)

    Campmans-Kuijpers, Marjo J E; Baan, Caroline A; Lemmens, Lidwien C; Rutten, Guy E H M

    2014-08-07

    In recent years, most Dutch general practitioners started working under the umbrella of diabetes care groups, responsible for the organisation and coordination of diabetes care. The quality management of these new organisations receives growing interest, although its association with quality of diabetes care is yet unclear. The best way to measure quality management is unknown and it has not yet been studied at the level of outpatient clinics or care groups. We aimed to assess quality management of type 2 diabetes care in care groups and outpatient clinics. Quality management was measured with online questionnaires, containing six domains (see below). They were divided into 28 subdomains, with 59 (care groups) and 57 (outpatient clinics) questions respectively. The mean score of the domains reflects the overall score (0-100%) of an organisation. Two quality managers of all Dutch care groups and outpatient clinics were invited to fill out the questionnaire.Sixty care groups (response rate 61.9%) showed a mean score of 59.6% (CI 57.1-62.1%). The average score in 52 outpatient clinics (response rate 50.0%) was 61.9% (CI 57.5-66.8%).Mean scores on the six domains for care groups and outpatient clinics respectively were: 'organisation of care' 71.9% (CI 68.8-74.9%), 76.8% (CI 72.8-80.7%); 'multidisciplinary teamwork' 67.1% (CI 62.4-71.9%), 71.5% (CI 65.3-77.8%); 'patient centeredness' 46.7% (CI 42.6-50.7%), 62.5% (CI 57.7-67.2%); 'performance management' 63.3% (CI 61.2-65.3%), 50.9% (CI 44.2-57.5%); 'quality improvement policy' 52.6% (CI 49.2-56.1%), 50.9% (CI 44.6-57.3%); and 'management strategies' 56.0% (CI 51.4-60.7%), 59.0% (CI 52.8-65.2%). On subdomains, care groups scored highest on 'care program' (83.3%) and 'measured outcomes' (98.3%) and lowest on 'patient safety' (15.1%) and 'patient involvement' (17.7%). Outpatient clinics scored high on the presence of a 'diabetic foot team' (81.6%) and the support in 'self-management' (81.0%) and low on 'patient

  13. Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

    Directory of Open Access Journals (Sweden)

    Humam Saltaji

    Full Text Available To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.Sequence generation was assessed to be inadequate (at unclear or high risk of bias in 68% (n = 367 of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%. Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154 and 40.5% (n = 219 of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427 of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95 of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%, while the method of blinding was appropriate in 53% (n = 286 of the trials. We identified a significant decrease over time (1955-2013 in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05 in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

  14. Costs and Clinical Quality Among Medicare Beneficiaries..

    Data.gov (United States)

    U.S. Department of Health & Human Services — Authors of Costs and Clinical Quality Among Medicare Beneficiaries - Associations with Health Center Penetration of Low-Income Residents, published in Volume 4,...

  15. A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

    Science.gov (United States)

    Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

    2013-07-01

    The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

  16. A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

    International Nuclear Information System (INIS)

    Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Xiao, Ying; Lee, Andrew J

    2013-01-01

    The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10–20 min to 2 min by applying the semi-automated plan-quality evaluation program. (note)

  17. Combining radiotherapy and ipilimumab induces clinically relevant radiation-induced abscopal effects in metastatic melanoma patients: A systematic review

    Directory of Open Access Journals (Sweden)

    Rodolfo Chicas-Sett

    2018-02-01

    Conclusion: Early clinical outcomes reports suggest that the combination of ipilimumab and RT may improve survival in metastatic melanoma patients. The abscopal responses become a clinically relevant effect of such combination and should be studied in controlled randomized trials.

  18. Paediatric case mix in a rural clinical school is relevant to future practice.

    Science.gov (United States)

    Wright, Helen M; Maley, Moira A L; Playford, Denese E; Nicol, Pam; Evans, Sharon F

    2017-11-29

    Exposure to a representative case mix is essential for clinical learning, with logbooks established as a way of demonstrating patient contacts. Few studies have reported the paediatric case mix available to geographically distributed students within the same medical school. Given international interest in expanding medical teaching locations to rural contexts, equitable case exposure in rural relative to urban settings is topical. The Rural Clinical School of Western Australia locates students up to 3500 km from the urban university for an academic year. There is particular need to examine paediatric case mix as a study reported Australian graduates felt unprepared for paediatric rotations. We asked: Does a rural clinical school provide a paediatric case mix relevant to future practice? How does the paediatric case mix as logged by rural students compare with that by urban students? The 3745 logs of 76 urban and 76 rural consenting medical students were categorised by presenting symptoms and compared to the Australian Institute of Health and Welfare (AIHW) database Major Diagnostic Categories (MDCs). Rural and urban students logged core paediatric cases, in similar order, despite the striking difference in geographic locations. The pattern of overall presenting problems closely corresponded to Australian paediatric hospital admissions. Rural students logged 91% of cases in secondary healthcare settings; urban students logged 90% of cases in tertiary settings. The top four presenting problems were ENT/respiratory, gastrointestinal/urogenital, neurodevelopmental and musculoskeletal; these made up 60% of all cases. Rural and urban students logged similar proportions of infants, children and adolescents, with a variety of case morbidity. Rural clinical school students logged a mix of core paediatric cases relevant to illnesses of Australian children admitted to public hospitals, with similar order and pattern by age group to urban students, despite major differences

  19. Comprehensive Clinical Audits of Diagnostic Radiology Practices: A Tool for Quality Improvement. Quality Assurance Audit for Diagnostic Radiology Improvement and Learning (QUAADRIL)

    International Nuclear Information System (INIS)

    2011-01-01

    Interest in quality assurance processes and quality improvement in diagnostic radiology is being driven by a number of factors. These include the high cost and complexity of radiological equipment, acknowledgement of the possibility of increasing doses to patients, and the importance of radiological diagnosis to patient management within the health care environment. To acknowledge these interests, clinical audits have been introduced and, in Europe, mandated under a European Directive (Council Directive 97/47/EURATOM). Comprehensive clinical audits focus on clinical management and infrastructure, patient related and technical procedures, and education and research. This publication includes a structured set of standards appropriate for diagnostic radiology, an audit guide to their clinical review, and data collection sheets for the rapid production of reports in audit situations. It will be a useful guide for diagnostic radiology facilities wishing to improve their service to patients through timely diagnosis with minimal radiation dose.

  20. Comprehensive Clinical Audits of Diagnostic Radiology Practices: A Tool for Quality Improvement. Quality Assurance Audit for Diagnostic Radiology Improvement and Learning (QUAADRIL)

    International Nuclear Information System (INIS)

    2010-01-01

    Interest in quality assurance processes and quality improvement in diagnostic radiology is being driven by a number of factors. These include the high cost and complexity of radiological equipment, acknowledgement of the possibility of increasing doses to patients, and the importance of radiological diagnosis to patient management within the health care environment. To acknowledge these interests, clinical audits have been introduced and, in Europe, mandated under a European Directive (Council Directive 97/47/EURATOM). Comprehensive clinical audits focus on clinical management and infrastructure, patient related and technical procedures, and education and research. This publication includes a structured set of standards appropriate for diagnostic radiology, an audit guide to their clinical review, and data collection sheets for the rapid production of reports in audit situations. It will be a useful guide for diagnostic radiology facilities wishing to improve their service to patients through timely diagnosis with minimal radiation dose.

  1. Towards a clinically relevant lentiviral transduction protocol for primary human CD34 hematopoietic stem/progenitor cells.

    Directory of Open Access Journals (Sweden)

    Michelle Millington

    2009-07-01

    Full Text Available Hematopoietic stem cells (HSC, in particular mobilized peripheral blood stem cells, represent an attractive target for cell and gene therapy. Efficient gene delivery into these target cells without compromising self-renewal and multi-potency is crucial for the success of gene therapy. We investigated factors involved in the ex vivo transduction of CD34(+ HSCs in order to develop a clinically relevant transduction protocol for gene delivery. Specifically sought was a protocol that allows for efficient transduction with minimal ex vivo manipulation without serum or other reagents of animal origin.Using commercially available G-CSF mobilized peripheral blood (PB CD34(+ cells as the most clinically relevant target, we systematically examined factors including the use of serum, cytokine combinations, pre-stimulation time, multiplicity of infection (MOI, transduction duration and the use of spinoculation and/or retronectin. A self-inactivating lentiviral vector (SIN-LV carrying enhanced green fluorescent protein (GFP was used as the gene delivery vehicle. HSCs were monitored for transduction efficiency, surface marker expression and cellular function. We were able to demonstrate that efficient gene transduction can be achieved with minimal ex vivo manipulation while maintaining the cellular function of transduced HSCs without serum or other reagents of animal origin.This study helps to better define factors relevant towards developing a standard clinical protocol for the delivery of SIN-LV into CD34(+ cells.

  2. The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

    NARCIS (Netherlands)

    Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

    1992-01-01

    Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

  3. Stem cell therapy for joint problems using the horse as a clinically relevant animal model

    DEFF Research Database (Denmark)

    Koch, Thomas Gadegaard; Betts, Dean H.

    2007-01-01

    of experimentally induced lesions. The horse lends itself as a good animal model of spontaneous joint disorders that are clinically relevant to similar human disorders. Equine stem cell and tissue engineering studies may be financially feasible to principal investigators and small biotechnology companies...

  4. Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives.

    Science.gov (United States)

    Chelico, John D; Wilcox, Adam B; Vawdrey, David K; Kuperman, Gilad J

    2016-01-01

    Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement.

  5. Development and application of two independent real-time PCR assays to detect clinically relevant Mucorales species.

    Science.gov (United States)

    Springer, Jan; Goldenberger, Daniel; Schmidt, Friderike; Weisser, Maja; Wehrle-Wieland, Elisabeth; Einsele, Hermann; Frei, Reno; Löffler, Jürgen

    2016-03-01

    PCR-based detection of Mucorales species could improve diagnosis of suspected invasive fungal infection, leading to a better patient outcome. This study describes two independent probe-based real-time PCR tests for detection of clinically relevant Mucorales, targeting specific fragments of the 18S and the 28S rRNA genes. Both assays have a short turnaround time, allow fast, specific and very sensitive detection of clinically relevant Mucorales and have the potential to be used as quantitative tests. They were validated on various clinical samples (fresh and formalin-fixed paraffin-embedded specimens, mainly biopsies, n = 17). The assays should be used as add-on tools to complement standard techniques; a combined approach of both real-time PCR assays has 100 % sensitivity. Genus identification by subsequent sequencing is possible for amplicons of the 18S PCR assay. In conclusion, combination of the two independent Mucorales assays described in this study, 18S and 28S, detected all clinical samples associated with proven Mucorales infection (n = 10). Reliable and specific identification of Mucorales is a prerequisite for successful antifungal therapy as these fungi show intrinsic resistance to voriconazole and caspofungin.

  6. The clinical relevance of assessing advanced glycation endproducts accumulation in diabetes

    Directory of Open Access Journals (Sweden)

    Hillebrands Jan-Luuk

    2008-10-01

    Full Text Available Abstract Cardiovascular disease is the major cause of morbidity and mortality associated with diabetes. There is increasing evidence that advanced glycation endproducts (AGEs play a pivotal role in atherosclerosis, in particular in diabetes. AGE accumulation is a measure of cumulative metabolic and oxidative stress, and may so represent the "metabolic memory". Furthermore, increased AGE accumulation is closely related to the development of cardiovascular complications in diabetes. This review article will focus on the clinical relevance of measuring AGE accumulation in diabetic patients by focusing on AGE formation, AGEs as predictors of long-term complications, and interventions against AGEs.

  7. Consideration of the relevance of standard quality techniques in Mass Customisation

    OpenAIRE

    Brabazon, Philip G.; MacCarthy, Bart L.

    2007-01-01

    The business philosophy of Mass Customisation (MC) implies rapid response to customer requests, high efficiency and limited cost overheads of customisation. Furthermore, it also implies the quality benefits of the mass production paradigm are guaranteed. However, traditional quality science in manufacturing is premised on volume production of uniform products rather than of differentiated products associated with MC. This creates quality challenges and raises questions over the suitability ...

  8. High dose-rate brachytherapy source position quality assurance using radiochromic film

    International Nuclear Information System (INIS)

    Evans, M.D.C.; Devic, S.; Podgorsak, E.B.

    2007-01-01

    Traditionally, radiographic film has been used to verify high-dose-rate brachytherapy source position accuracy by co-registering autoradiographic and diagnostic images of the associated applicator. Filmless PACS-based clinics that do not have access to radiographic film and wet developers may have trouble performing this quality assurance test in a simple and practical manner. We describe an alternative method for quality assurance using radiochromic-type film. In addition to being easy and practical to use, radiochromic film has some advantages in comparison with traditional radiographic film when used for HDR brachytherapy quality assurance

  9. Measuring the quality of clinical audit projects.

    Science.gov (United States)

    Millard, A D

    2000-11-01

    The aim of the study was to develop and pilot a scale measuring the quality of audit projects through audit project reports. Statements about clinical audit projects were selected from existing instruments assessing the quality of clinical audit projects to form a Likert scale. Audit facilitators based in Scottish health boards and trusts piloted the scale. The participants were known to have over 2 years of experience of supporting clinical audit. The response at first test was 11 of 14 and at the second test 27 of 46. Audit facilitators tested the draft scale by expressing their strength of agreement or disagreement with each statement for three reports. Validity and reliability were assessed by test - re-test, item - total, and total - global indicator correlation. Of the 20 statements, 15 had satisfactory correlation with scale totals. Scale totals had good correlation with global indicators. Test re-test correlation was modest. The wide range of responses means further research is needed to measure the consistency of audit facilitators' interpretations, perhaps comparing a trained group with an untrained group. There may be a need for a separate scale for reaudits. Educational impact is distinct from project impact generally. It may be more meaningful to treat the selection of projects and aims, methodology and impact separately as subscales and take a project profiling approach rather than attempting to produce a global quality index.

  10. The Mentalization-Based Therapy Adherence and Quality Scale (MBT-AQS): Reliability in a clinical setting

    DEFF Research Database (Denmark)

    Simonsen, Sebastian; Juul, Sophie; Kongerslev, Mickey

    2018-01-01

    The Mentalization-Based Treatment Adherence and Quality Scale (MBT-AQS) is a 17-item measure of treatment adherence and quality of individual mentalization-based therapy (MBT). Until now, reliability research on the scale has primarily been conducted by highly experienced raters from the Norwegian...... MBT therapists in a clinical setting following a brief one-day training course. The overall reliabilities for six raters were good for adherence (.67) and for quality (.62). Thus, the MBT-AQS was found to be an appropriate MBT adherence rating instrument with clinical and educational utility outside...... MBT Quality Lab who were part of its development. Hence, it can be questioned whether only experts in research settings can achieve satisfying levels of reliability on the scale. In this study, we investigated whether a satisfying level of reliability on the MBT-AQS could be obtained by experienced...

  11. Pregnancy outcomes in Ghana : Relavance of clinical decision making support tools for frontline providers of care

    OpenAIRE

    Amoakoh-Coleman, M.

    2016-01-01

    Ghana’s slow progress towards attaining millennium development goal 5 has been associated with gaps in quality of care, particularly quality of clinical decision making for clients. This thesis reviews the relevance and effect of clinical decision making support tools on pregnancy outcomes. Relevance of three clinical decision making support tools available to frontline providers of care in the Greater Accra region is discussed. These are routine maternal health service delivery data populati...

  12. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  13. Relevance of MICA and other non-HLA antibodies in clinical transplantation.

    Science.gov (United States)

    Sumitran-Holgersson, Suchitra

    2008-10-01

    The clinical importance of HLA-specific antibodies for organ allograft outcome is well established. In the past few years, there has been an increasing interest in non-HLA antigens as targets of injury in organ transplant recipients. This increased interest has been spurred by the fact that HLA-identical kidney transplants also undergo immunological rejections. Polymorphisms within non-HLA genes associated with evoking an immune response to alloantigens are currently being studied for their association with transplant outcome. Non-HLA antigens, such as the polymorphic MHC class I-related chain A (MICA), expressed on endothelial cells have been implicated in the pathogenesis of hyperacute, acute and chronic organ allograft rejections. Use of endothelial cells as targets may clarify the specificities of other clinically relevant non-HLA antibodies in graft rejections. This review summarizes past and current knowledge of the clinical importance and specificities of non-HLA antibodies, and mechanisms by which these antibodies may contribute to graft destruction in clinical transplantation. The aims of current research into the role of non-HLA antigens and their genetics in predicting outcome are to develop an improved insight into the basic science of transplantation and to develop a risk or prognostic index for use in the clinical setting. Non-HLA antibody responses are receiving increasing interest in acute and chronic rejection and specificity, affinity, and pathogenicity need to be investigated to estimate their contribution. Undoubtedly, this will continue to be an area of interest in terms of fully understanding the role of non-HLA antigens as targets of immune-mediated injury and the potential for clinical intervention.

  14. Quality in transitional care of the elderly: Key challenges and relevant improvement measures

    Directory of Open Access Journals (Sweden)

    Marianne Storm

    2014-05-01

    Full Text Available Introduction: Elderly people aged over 75 years with multifaceted care needs are often in need of hospital treatment. Transfer across care levels for this patient group increases the risk of adverse events. The aim of this paper is to establish knowledge of quality in transitional care of the elderly in two Norwegian hospital regions by identifying issues affecting the quality of transitional care and based on these issues suggest improvement measures.Methodology: Included in the study were elderly patients (75+ receiving health care in the municipality admitted to hospital emergency department or discharged to community health care with hip fracture or with a general medical diagnosis. Participant observations of admission and discharge transitions (n = 41 were carried out by two researchers.Results: Six main challenges with belonging descriptions have been identified: (1 next of kin (bridging providers, advocacy, support, information brokering, (2 patient characteristics (level of satisfaction, level of insecurity, complex clinical conditions, (3 health care personnel's competence (professional, system, awareness of others’ roles, (4 information exchange (oral, written, electronic, (5 context (stability, variability, change incentives, number of patient handovers and (6 patient assessment (complex clinical picture, patient description, clinical assessment.Conclusion: Related to the six main challenges, several measures have been suggested to improve quality in transitional care, e.g. information to and involvement of patients and next of kin, staff training, standardisation of routines and inter-organisational staff meetings.

  15. Ensuring on-time quality data management deliverables from global clinical data management teams

    Directory of Open Access Journals (Sweden)

    Zia Haque

    2010-01-01

    Full Text Available The growing emphasis on off-site and off-shore clinical data management activities mandates a paramount need for adequate solutions geared toward on-time, quality deliverables. The author has been leading large teams that have been involved in successful global clinical data management endeavors. While each study scenario is unique and has to be approached as such, there are several elements in defining strategy and team structure in global clinical data management that can be applied universally. In this article, key roles, practices, and high-level procedures are laid out as a road map to ensure success with the model.

  16. Comparison of clinical and physical measures of image quality in chest and pelvis computed radiography at different tube voltages

    International Nuclear Information System (INIS)

    Sandborg, Michael; Tingberg, Anders; Ullman, Gustaf; Dance, David R.; Alm Carlsson, Gudrun

    2006-01-01

    The aim of this work was to study the dependence of image quality in digital chest and pelvis radiography on tube voltage, and to explore correlations between clinical and physical measures of image quality. The effect on image quality of tube voltage in these two examinations was assessed using two methods. The first method relies on radiologists' observations of images of an anthropomorphic phantom, and the second method was based on computer modeling of the imaging system using an anthropomorphic voxel phantom. The tube voltage was varied within a broad range (50-150 kV), including those values typically used with screen-film radiography. The tube charge was altered so that the same effective dose was achieved for each projection. Two x-ray units were employed using a computed radiography (CR) image detector with standard tube filtration and antiscatter device. Clinical image quality was assessed by a group of radiologists using a visual grading analysis (VGA) technique based on the revised CEC image criteria. Physical image quality was derived from a Monte Carlo computer model in terms of the signal-to-noise ratio, SNR, of anatomical structures corresponding to the image criteria. Both the VGAS (visual grading analysis score) and SNR decrease with increasing tube voltage in both chest PA and pelvis AP examinations, indicating superior performance if lower tube voltages are employed. Hence, a positive correlation between clinical and physical measures of image quality was found. The pros and cons of using lower tube voltages with CR digital radiography than typically used in analog screen-film radiography are discussed, as well as the relevance of using VGAS and quantum-noise SNR as measures of image quality in pelvis and chest radiography

  17. Evaluating quality indicators for patients with community-acquired pneumonia.

    Science.gov (United States)

    Rhew, D C; Goetz, M B; Shekelle, P G

    2001-11-01

    Several organizations have published evidence-based quality indicators for community-acquired pneumonia (CAP). However, there is variability in the types of indicators presented between organizations and the level of supporting evidence for each of the indicators. A systematic review of the literature and relevant Internet Web sites was performed to identify quality indicators for CAP that have been proposed or recommended by organizations, and each of the indicators was then critically appraised, using a well-defined set of criteria. The MEDLINE, EMBASE, Best Evidence, and Cochrane Systematic Review databases and Internet Web sites were searched for articles and guidelines published between January 1980 and May 2001 to identify quality indicators for CAP and relevant evidence. Experts in the area of health services research were contacted to identify additional sources. A well-defined set of criteria was applied to evaluate each of the quality indicators. The systematic review of the literature and Internet Web sites yielded 44 CAP-specific quality indicators. The critical appraisal of these indicators yielded 16 indicators that were supported by a study that identified an association between quality of care and the process of care or outcome measure, were applied to enough patients to be able to detect clinically meaningful differences, were clinically and/or economically relevant, were measurable in a clinical practice setting, and were precise in their specifications. Many organizations recommend indicators for CAP. Indicators may serve as measures of clinical performance for clinicians and hospitals, may help in benchmarking, and may ultimately facilitate improvements in quality of care and cost reductions. However, CAP indicators often vary in their meaningfulness, scientific soundness, and interpretability of results. A set of five critical appraisal questions may assist in the evaluation of which quality indicators are most valid.

  18. The high vaginal swab in general practice: clinical correlates of possible pathogens.

    Science.gov (United States)

    Dykhuizen, R S; Harvey, G; Gould, I M

    1995-06-01

    Clinical features, diagnosis and treatment of 286 women whose high vaginal swabs (HVS) submitted by their general practitioners showed pure, heavy growth of Staphylococcus aureus, beta haemolytic streptococci groups A, C or G, Streptococcus milleri, Streptococcus pneumoniae or Haemophilus influenzae were analysed. Women with group A, C and G streptococci frequently had clinical vulvovaginitis and although the numbers were too small for statistical confirmation, S. pneumoniae and H. influenzae appeared to cause clinical disease as well. The association of S. aureus or S. milleri with clinical vulvovaginitis was much less convincing. It seems relevant for laboratories to report sensitivities for group A, C and G streptococci. Further research is needed to determine the pathogenicity of S. pneumoniae and H. influenzae.

  19. Definition of a core set of quality indicators for the assessment of HIV/AIDS clinical care: a systematic review

    Science.gov (United States)

    2013-01-01

    Background Several organizations and individual authors have been proposing quality indicators for the assessment of clinical care in HIV/AIDS patients. Nevertheless, the definition of a consensual core set of indicators remains controversial and its practical use is largely limited. This study aims not only to identify and characterize these indicators through a systematic literature review but also to propose a parsimonious model based on those most used. Methods MEDLINE, SCOPUS, Cochrane databases and ISI Web of Knowledge, as well as official websites of organizations dealing with HIV/AIDS care, were searched for articles and information proposing HIV/AIDS clinical care quality indicators. The ones that are on patient’s perspective and based on services set were excluded. Data extraction, using a predefined data sheet based on Cochrane recommendations, was done by one of the authors while a second author rechecked the extracted data for any inconsistency. Results A total of 360 articles were identified in our search query but only 12 of them met the inclusion criteria. We also identified one relevant site. Overall, we identified 65 quality indicators for HIV/AIDS clinical care distributed as following: outcome (n=15) and process-related (n=50) indicators; generic (n=36) and HIV/AIDS disease-specific (n=29) indicators; baseline examinations (n=19), screening (n=9), immunization (n=4), prophylaxis (n=5), HIV monitoring (n=16), and therapy (=12) indicators. Conclusions There are several studies that set up HIV clinical care indicators, with only a part of them useful to assess the HIV clinical care. More importantly, HIV/AIDS clinical care indicators need to be valid, reliable and most of all feasible. PMID:23809537

  20. Information systems as a quality management tool in clinical laboratories

    Science.gov (United States)

    Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

    2007-11-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

  1. Information systems as a quality management tool in clinical laboratories

    International Nuclear Information System (INIS)

    Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el

    2007-01-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system

  2. Biomarkers for AAA: Encouraging steps but clinical relevance still to be delivered.

    Science.gov (United States)

    Htun, Nay Min; Peter, Karlheinz

    2014-10-01

    Potential biomarkers have been investigated using proteomic studies in a variety of diseases. Some biomarkers have central roles in both diagnosis and monitoring of various disorders in clinical medicine, such as troponins, brain natriuretic peptide, and C-reactive protein. Although several biomarkers have been suggested in human abdominal aortic aneurysm (AAA), reliable markers have been lacking. In this issue, Moxon et al. [Proteomics Clin Appl. 2014, 8, 762-772] undertook a broad and systematic proteomic approach toward identification of biomarkers in a commonly used AAA mouse model (AAA created by angiotensin-II infusion). In this mouse model, apolipoprotein C1 and matrix metalloproteinase-9 were identified as novel biomarkers of stable AAA. This finding represents an important step forward, toward a clinically relevant role of biomarkers in AAA. This also encourages for further studies toward the identification of biomarkers (or their combinations) that can predict AAA progression and rupture, which would represent a major progress in AAA management and would establish an AAA biomarker as a much anticipated clinical tool. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  3. Defining High-Quality Palliative Care in Oncology Practice: An American Society of Clinical Oncology/American Academy of Hospice and Palliative Medicine Guidance Statement.

    Science.gov (United States)

    Bickel, Kathleen E; McNiff, Kristen; Buss, Mary K; Kamal, Arif; Lupu, Dale; Abernethy, Amy P; Broder, Michael S; Shapiro, Charles L; Acheson, Anupama Kurup; Malin, Jennifer; Evans, Tracey; Krzyzanowska, Monika K

    2016-09-01

    Integrated into routine oncology care, palliative care can improve symptom burden, quality of life, and patient and caregiver satisfaction. However, not all oncology practices have access to specialist palliative medicine. This project endeavored to define what constitutes high-quality primary palliative care as delivered by medical oncology practices. An expert steering committee outlined 966 palliative care service items, in nine domains, each describing a candidate element of primary palliative care delivery for patients with advanced cancer or high symptom burden. Using modified Delphi methodology, 31 multidisciplinary panelists rated each service item on three constructs: importance, feasibility, and scope within medical oncology practice. Panelists endorsed the highest proportion of palliative care service items in the domains of End-of-Life Care (81%); Communication and Shared Decision Making (79%); and Advance Care Planning (78%). The lowest proportions were in Spiritual and Cultural Assessment and Management (35%) and Psychosocial Assessment and Management (39%). In the largest domain, Symptom Assessment and Management, there was consensus that all symptoms should be assessed and managed at a basic level, with more comprehensive management for common symptoms such as nausea, vomiting, diarrhea, dyspnea, and pain. Within the Appropriate Palliative Care and Hospice Referral domain, there was consensus that oncology practices should be able to describe the difference between palliative care and hospice to patients and refer patients appropriately. This statement describes the elements comprising high-quality primary palliative care for patients with advanced cancer or high symptom burden, as delivered by oncology practices. Oncology providers wishing to enhance palliative care delivery may find this information useful to inform operational changes and quality improvement efforts. Copyright © 2016 by American Society of Clinical Oncology.

  4. Relevance of a subjective quality of life questionnaire for long-term homeless persons with schizophrenia.

    Science.gov (United States)

    Girard, V; Tinland, A; Bonin, J P; Olive, F; Poule, J; Lancon, C; Apostolidis, T; Rowe, M; Greacen, T; Simeoni, M C

    2017-02-17

    Increasing numbers of programs are addressing the specific needs of homeless people with schizophrenia in terms of access to housing, healthcare, basic human rights and other domains. Although quality of life scales are being used to evaluate such programs, few instruments have been validated for people with schizophrenia and none for people with schizophrenia who experience major social problems such as homelessness. The aim of the present study was to validate the French version of the S-QoL a self-administered, subjective quality of life questionnaire specific to schizophrenia for people with schizophrenia who are homeless. In a two-step process, the S-QoL was first administered to two independent convenience samples of long-term homeless people with schizophrenia in Marseille, France. The objective of the first step was to analyse the psychometric properties of the S-QoL. The objective of the second step was to examine, through qualitative interviews with members of the population in question, the relevance and acceptability of the principle quality of life indicators used in the S-QoL instrument. Although the psychometric characteristics of the S-QoL were found to be globally satisfactory, from the point of view of the people being interviewed, acceptability was poor. Respondents frequently interrupted participation complaining that questionnaire items did not take into account the specific context of life on the streets. Less intrusive questions, more readily understandable vocabulary and greater relevance to subjects' living conditions are needed to improve the S-QoL questionnaire for this population. A modular questionnaire with context specific sections or specific quality of life instruments for socially excluded populations may well be the way forward.

  5. Helical Tomotherapy Quality Assurance

    International Nuclear Information System (INIS)

    Balog, John; Soisson, Emilie

    2008-01-01

    Helical tomotherapy uses a dynamic delivery in which the gantry, treatment couch, and multileaf collimator leaves are all in motion during treatment. This results in highly conformal radiotherapy, but the complexity of the delivery is partially hidden from the end-user because of the extensive integration and automation of the tomotherapy control systems. This presents a challenge to the medical physicist who is expected to be both a system user and an expert, capable of verifying relevant aspects of treatment delivery. A related issue is that a clinical tomotherapy planning system arrives at a customer's site already commissioned by the manufacturer, not by the clinical physicist. The clinical physicist and the manufacturer's representative verify the commissioning at the customer site before acceptance. Theoretically, treatment could begin immediately after acceptance. However, the clinical physicist is responsible for the safe and proper use of the machine. In addition, the therapists and radiation oncologists need to understand the important machine characteristics before treatment can proceed. Typically, treatment begins about 2 weeks after acceptance. This report presents an overview of the tomotherapy system. Helical tomotherapy has unique dosimetry characteristics, and some of those features are emphasized. The integrated treatment planning, delivery, and patient-plan quality assurance process is described. A quality assurance protocol is proposed, with an emphasis on what a clinical medical physicist could and should check. Additionally, aspects of a tomotherapy quality assurance program that could be checked automatically and remotely because of its inherent imaging system and integrated database are discussed

  6. Processes for Quality Improvements in Radiation Oncology Clinical Trials

    International Nuclear Information System (INIS)

    FitzGerald, T.J.; Urie, Marcia; Ulin, Kenneth; Laurie, Fran; Yorty, Jeffrey C.; Hanusik, Richard; Kessel, Sandy; Jodoin, Maryann Bishop; Osagie, Gani; Cicchetti, M. Giulia; Pieters, Richard; McCarten, Kathleen; Rosen, Nancy

    2008-01-01

    Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials

  7. Clinically applied medical ethnography: relevance to cultural competence in patient care.

    Science.gov (United States)

    Engebretson, Joan

    2011-06-01

    Medical anthropology provides an excellent resource for nursing research that is relevant to clinical nursing. By expanding the understanding of ethnographic research beyond ethnicity, nurses can conduct research that explores patient's constructions and explanatory models of health and healing and how they make meaning out of chronic conditions and negotiate daily life. These findings can have applicability to culturally competent care at both the organizational or systems level, as well as in the patient/provider encounter. Individual patient care can be improved by applying ethnographic research findings to build provider expertise and then using a cultural negotiation process for individualized patient care. Copyright © 2011. Published by Elsevier Inc.

  8. Fabrication of high-quality single-crystal Cu thin films using radio-frequency sputtering.

    Science.gov (United States)

    Lee, Seunghun; Kim, Ji Young; Lee, Tae-Woo; Kim, Won-Kyung; Kim, Bum-Su; Park, Ji Hun; Bae, Jong-Seong; Cho, Yong Chan; Kim, Jungdae; Oh, Min-Wook; Hwang, Cheol Seong; Jeong, Se-Young

    2014-08-29

    Copper (Cu) thin films have been widely used as electrodes and interconnection wires in integrated electronic circuits, and more recently as substrates for the synthesis of graphene. However, the ultra-high vacuum processes required for high-quality Cu film fabrication, such as molecular beam epitaxy (MBE), restricts mass production with low cost. In this work, we demonstrated high-quality Cu thin films using a single-crystal Cu target and radio-frequency (RF) sputtering technique; the resulting film quality was comparable to that produced using MBE, even under unfavorable conditions for pure Cu film growth. The Cu thin film was epitaxially grown on an Al2O3 (sapphire) (0001) substrate, and had high crystalline orientation along the (111) direction. Despite the 10(-3) Pa vacuum conditions, the resulting thin film was oxygen free due to the high chemical stability of the sputtered specimen from a single-crystal target; moreover, the deposited film had >5× higher adhesion force than that produced using a polycrystalline target. This fabrication method enabled Cu films to be obtained using a simple, manufacturing-friendly process on a large-area substrate, making our findings relevant for industrial applications.

  9. Relevant Criteria for Testing the Quality of Models for Turbulent Wind Speed Fluctuations

    DEFF Research Database (Denmark)

    Frandsen, Sten Tronæs; Ejsing Jørgensen, Hans; Sørensen, John Dalsgaard

    2008-01-01

    Seeking relevant criteria for testing the quality of turbulence models, the scale of turbulence and the gust factor have been estimated from data and compared with predictions from first-order models of these two quantities. It is found that the mean of the measured length scales is approximately...... 10% smaller than the IEC model for wind turbine hub height levels. The mean is only marginally dependent on trends in time series. It is also found that the coefficient of variation of the measured length scales is about 50%. 3  s and 10  s preaveraging of wind speed data are relevant for megawatt......-size wind turbines when seeking wind characteristics that correspond to one blade and the entire rotor, respectively. For heights exceeding 50-60  m, the gust factor increases with wind speed. For heights larger than 60-80  m, present assumptions on the value of the gust factor are significantly...

  10. Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

    Directory of Open Access Journals (Sweden)

    Mulugeta A

    2016-12-01

    Full Text Available Anwar Mulugeta,1 Girmay Medhin,2 Getnet Yimer,1 Rahimush Jemal,3 Abebaw Fekadu,4,5 1Department of Pharmacology, School of Medicine, College of Health Sciences, Addis Ababa University, 2Aklilu Lemma Institute of Pathobiology, Addis Ababa University, 3Department of Pharmacy, Tikur Anbesa Hospital, 4Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 5Department of Psychological Medicine, Centre for Affective Disorders, Institute of Psychiatry, King’s College London, London, UK Background: There is a developing consensus on the effectiveness of various interventions for mental disorders in low- and middle-income countries, and it has been proposed that the main task is to scale up these interventions. In this context, we aimed to review the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa.Methods: Medline and African Journals Online databases were used for searching relevant articles. Both randomized and nonrandomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder, and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy, and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions, and study types were employed. The qualities of the trials were appraised using the single-component quality assessment of the consolidated standards of reporting trials (CONSORT statement and the Jadad scale.Results: From 1,136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and were conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34 studies. Approximately half of the trials (53% were conducted in single center and the majority

  11. Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics.

    Science.gov (United States)

    Hahn, Daniel; Wanjala, Pepela; Marx, Michael

    2013-08-29

    Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily) for patient care. A multiple case study was carried out between March and August 2012 at the antenatal care (ANC) clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC). Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers) and individual skills and motivation.

  12. Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics

    Directory of Open Access Journals (Sweden)

    Daniel Hahn

    2013-08-01

    Full Text Available Background: Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily for patient care. Design: A multiple case study was carried out between March and August 2012 at the antenatal care (ANC clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC. Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Results: Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. Conclusions: We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers and individual skills and motivation.

  13. Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics

    Science.gov (United States)

    Hahn, Daniel; Wanjala, Pepela; Marx, Michael

    2013-01-01

    Background Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily) for patient care. Design A multiple case study was carried out between March and August 2012 at the antenatal care (ANC) clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC). Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Results Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. Conclusions We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers) and individual skills and motivation. PMID:23993022

  14. The Quality of Clinical Maternal and Neonatal Healthcare – A Strategy for Identifying ‘Routine Care Signal Functions’

    Science.gov (United States)

    Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S.

    2015-01-01

    Background A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the ‘EmOC signal functions’, a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. Methods We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Results Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants’ adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. Conclusion The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes

  15. Improved clinical status, quality of life, and walking capacity in Parkinson's disease after body weight-supported high-intensity locomotor training.

    Science.gov (United States)

    Rose, Martin H; Løkkegaard, Annemette; Sonne-Holm, Stig; Jensen, Bente R

    2013-04-01

    To evaluate the effect of body weight-supported progressive high-intensity locomotor training in Parkinson's disease (PD) on (1) clinical status; (2) quality of life; and (3) gait capacity. Open-label, fixed sequence crossover study. University motor control laboratory. Patients (N=13) with idiopathic PD (Hoehn and Yahr stage 2 or 3) and stable medication use. Patients completed an 8-week (3 × 1h/wk) training program on a lower-body positive-pressure treadmill. Body weight support was used to facilitate increased intensity and motor challenges during treadmill training. The training program contained combinations of (1) running and walking intervals, (2) the use of sudden changes (eg, in body weight support and speed), (3) different types of locomotion (eg, chassé, skipping, and jumps), and (4) sprints at 50 percent body weight. The Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire-39 items (PDQ-39), and the six-minute walk test were conducted 8 weeks before and pre- and posttraining. At the end of training, statistically significant improvements were found in all outcome measures compared with the control period. Total MDS-UPDRS score changed from (mean ± 1SD) 58±18 to 47±18, MDS-UPDRS motor part score changed from 35±10 to 29±12, PDQ-39 summary index score changed from 22±13 to 13±12, and the six-minute walking distance changed from 576±93 to 637±90m. Body weight-supported progressive high-intensity locomotor training is feasible and well tolerated by patients with PD. The training improved clinical status, quality of life, and gait capacity significantly. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  16. The effect of the amiodarone-warfarin interaction on anticoagulation quality in a single, high-quality anticoagulation center.

    Science.gov (United States)

    White, Ryan D; Riggs, Kyle W; Ege, Ed J; Petroski, Gregory F; Koerber, Scott M; Flaker, Greg

    2016-03-01

    Clinical trials have reported a low time in therapeutic range (TTR) in patients with atrial fibrillation treated with both warfarin andamiodarone. These trials included centers and countries with both high and low TTRs. What is the impact of amiodarone on the TTR in a single, high-quality anticoagulation clinic? TTR was assessed in amiodarone and nonamiodarone-treated patients from a University anticoagulation clinic. Baseline characteristics between patients ever-taking or never-taking amiodarone were similar, except more amiodarone patients were smokers (19.5 vs. 6.1%, P = 0.0031). The TTR calculated from 8901international normalized ratios (INRs) in 249 nonamiodarone patients with a mean follow-up of 34 ± 20 months (mean INR 36 ± 18) was 66 ± 16.6% compared with 61.3 ± 16.2% (P = 0.111) from 1455 INRs in 41 amiodarone-treated patients with a mean follow-up of 28 ± 20 months (mean INR 35 ± 22). Factors associated with a low TTR were male sex (P = 0.0013), smoker (P = 0.0048), and amiodarone use (P = 0.0374). A second on-treatment analysis, in which the TTR was calculated only during amiodarone therapy, resulted in similar findings; however, amiodarone did not emerge as a predictor of a low TTR. In 11 patients, the TTR prior to amiodarone (54.5 ± 22.2%) was not significantly different in the first 3 months (54.6 ± 33.4%) or after 3 months (67.2 ± 33.7%) of amiodarone. In a single high-quality anticoagulation center, anticoagulation quality, as measured by the TTR, can be comparable in amiodarone and nonamiodarone-treated patients.

  17. Evaluation of quality of life in oncology clinic

    International Nuclear Information System (INIS)

    Jarema, A.; Marzecki, Z.

    1994-01-01

    In 18 patients with various malignancies the quality of life was evaluated with the use of the SF-36 questionnaire before and after radiotherapy. The quality of life was better among patients whose physical condition was better both before and after radiotherapy. The quality of life deteriorated after radiotherapy in patients whose physical status before treatment was evaluated as more serious. After the treatment the correlation was found between the global evaluation of quality of life and the intensity of pain and physical disability. However, both before and after radiotherapy the correlation was found between global quality of life and the severity of depression. The subjective estimation of quality of life by cancer patients did not correlate with the clinical evaluation of the severity of their state in doctor's opinion. (author)

  18. Practical evaluation of clinical image quality (4). Determination of image quality in digital radiography system

    International Nuclear Information System (INIS)

    Katayama, Reiji

    2016-01-01

    Recently, for medical imaging, digital radiography systems are widely used in clinical practices. However, a study in the past reported that a patient radiation exposure level by digital radiography is in fact not lower than that by analog radiography system. High level of attention needs to be paid for over-exposure when using the conventional analog radiography with a screen and a film, as it results in high density of the film. However, for digital radiography systems, since the automatic adjusting function of image density is equipped with them, no attention for radiation dose need to be paid. Thus technologists tend to be careless and results in higher chance for over-exposure. Current digital radiography systems are high-performance in the image properties and capable of patient dose reduction. Especially, the image quality of the flat panel detector system is recognized, higher than that of the computed radiography system by imaging plates, in both objective and subjective evaluations. Therefore, we technologists are responsible for optimizing the balance between the image quality of the digital radiogram and the radiation dose required for each case. Moreover, it is also required for us as medical technologists to make effective use of such evaluation result of medical images for patients. (author)

  19. Evaluation of features to support safety and quality in general practice clinical software

    Science.gov (United States)

    2011-01-01

    Background Electronic prescribing is now the norm in many countries. We wished to find out if clinical software systems used by general practitioners in Australia include features (functional capabilities and other characteristics) that facilitate improved patient safety and care, with a focus on quality use of medicines. Methods Seven clinical software systems used in general practice were evaluated. Fifty software features that were previously rated as likely to have a high impact on safety and/or quality of care in general practice were tested and are reported here. Results The range of results for the implementation of 50 features across the 7 clinical software systems was as follows: 17-31 features (34-62%) were fully implemented, 9-13 (18-26%) partially implemented, and 9-20 (18-40%) not implemented. Key findings included: Access to evidence based drug and therapeutic information was limited. Decision support for prescribing was available but varied markedly between systems. During prescribing there was potential for medicine mis-selection in some systems, and linking a medicine with its indication was optional. The definition of 'current medicines' versus 'past medicines' was not always clear. There were limited resources for patients, and some medicines lists for patients were suboptimal. Results were provided to the software vendors, who were keen to improve their systems. Conclusions The clinical systems tested lack some of the features expected to support patient safety and quality of care. Standards and certification for clinical software would ensure that safety features are present and that there is a minimum level of clinical functionality that clinicians could expect to find in any system.

  20. Taijin Kyofusho and Social Anxiety and their clinical relevance in Indonesia and Switzerland

    OpenAIRE

    Vriends, Noortje; Pfaltz, Monique C.; Novianti, Peppy; Hadiyono, Johana

    2013-01-01

    Background: Taijin Kyofusho (TKS) is an interpersonal fear to offend others and is defined by DSM-IV as a culturally bound syndrome that occurs in Japan and Korea. Recently, cases with TKS have also been recognized in other cultures. The present questionnaire study investigated self-report TKS symptoms and social anxiety symptoms, and their clinical relevance in an Indonesian and Swiss sample. It also investigated if self-construal is associated with TKS and social anxiety, and if self-constr...

  1. Taijin Kyofusho and Social Anxiety and Their Clinical Relevance in Indonesia and Switzerland

    OpenAIRE

    Vriends, N.; Pfaltz, M. C.; Novianti, P.; Hadiyono, J.

    2013-01-01

    Background: Taijin Kyofusho Scale (TKS) is an interpersonal fear to offend others and is defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) as a culturally bound syndrome that occurs in Japan and Korea. Recently, cases with TKS have also been recognized in other cultures. The present questionnaire study investigated self-report TKS symptoms and social anxiety symptoms, and their clinical relevance in an Indonesian and Swiss sample. It also investigated whether self-cons...

  2. Taijin Kyofusho and Social Anxiety and their clinical relevance in Indonesia and Switzerland

    OpenAIRE

    Noortje eVriends; Noortje eVriends; Monique C Pfaltz; Peppy eNovianti; Johana eHadiyono

    2013-01-01

    Background: Taijin Kyofusho (TKS) is an interpersonal fear to offend others and is defined by DSM-IV as a culturally bound syndrome that occurs in Japan and Korea. Recently, cases with TKS have also been recognized in other cultures. The present questionnaire study investigated self-report TKS symptoms and social anxiety symptoms, and their clinical relevance in an Indonesian and Swiss sample. It also investigated if self-construal is associated with TKS and social anxiety, and if self-const...

  3. Database Quality and Access Issues Relevant to Research Using Anesthesia Information Management System Data.

    Science.gov (United States)

    Epstein, Richard H; Dexter, Franklin

    2018-07-01

    For this special article, we reviewed the computer code, used to extract the data, and the text of all 47 studies published between January 2006 and August 2017 using anesthesia information management system (AIMS) data from Thomas Jefferson University Hospital (TJUH). Data from this institution were used in the largest number (P = .0007) of papers describing the use of AIMS published in this time frame. The AIMS was replaced in April 2017, making this finite sample finite. The objective of the current article was to identify factors that made TJUH successful in publishing anesthesia informatics studies. We examined the structured query language used for each study to examine the extent to which databases outside of the AIMS were used. We examined data quality from the perspectives of completeness, correctness, concordance, plausibility, and currency. Our results were that most could not have been completed without external database sources (36/47, 76.6%; P = .0003 compared with 50%). The operating room management system was linked to the AIMS and was used significantly more frequently (26/36, 72%) than other external sources. Access to these external data sources was provided, allowing exploration of data quality. The TJUH AIMS used high-resolution timestamps (to the nearest 3 milliseconds) and created audit tables to track changes to clinical documentation. Automatic data were recorded at 1-minute intervals and were not editable; data cleaning occurred during analysis. Few paired events with an expected order were out of sequence. Although most data elements were of high quality, there were notable exceptions, such as frequent missing values for estimated blood loss, height, and weight. Some values were duplicated with different units, and others were stored in varying locations. Our conclusions are that linking the TJUH AIMS to the operating room management system was a critical step in enabling publication of multiple studies using AIMS data. Access to this and

  4. Sleep quantity, quality, and insomnia symptoms of medical students during clinical years. Relationship with stress and academic performance.

    Science.gov (United States)

    Alsaggaf, Mohammed A; Wali, Siraj O; Merdad, Roah A; Merdad, Leena A

    2016-02-01

    To determine sleep habits and sleep quality in medical students during their clinical years using validated measures; and to investigate associations with academic performance and psychological stress. In this cross-sectional study, medical students (n=320) were randomly selected from a list of all enrolled clinical-year students in a Saudi medical school from 2011-2012. Students filled a questionnaire including demographic and lifestyle factors, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and Perceived Stress Scale. Students acquired on average, 5.8 hours of sleep each night, with an average bedtime at 01:53. Approximately 8% reported acquiring sleep during the day, and not during nighttime. Poor sleep quality was present in 30%, excessive daytime sleepiness (EDS) in 40%, and insomnia symptoms in 33% of students. Multivariable regression models revealed significant associations between stress, poor sleep quality, and EDS. Poorer academic performance and stress were associated with symptoms of insomnia. Sleep deprivation, poor sleep quality, and EDS are common among clinical years medical students. High levels of stress and the pressure of maintaining grade point averages may be influencing their quality of sleep.

  5. [Quality management in a clinical research facility: Evaluation of changes in quality in-house figures and the appraisal of in-house quality indicators].

    Science.gov (United States)

    Aden, Bile; Allekotte, Silke; Mösges, Ralph

    2016-12-01

    For long-term maintenance and improvement of quality within a clinical research institute, the implementation and certification of a quality management system is suitable. Due to the implemented quality management system according to the still valid DIN EN ISO 9001:2008 desired quality objectives are achieved effectively. The evaluation of quality scores and the appraisal of in-house quality indicators make an important contribution in this regard. In order to achieve this and draw quality assurance conclusions, quality indicators as sensible and sensitive as possible are developed. For this, own key objectives, the retrospective evaluation of quality scores, a prospective follow-up and also discussions establish the basis. In the in-house clinical research institute the measures introduced by the quality management led to higher efficiency in work processes, improved staff skills, higher customer satisfaction and overall to more successful outcomes in relation to the self-defined key objectives. Copyright © 2016. Published by Elsevier GmbH.

  6. Scoring relevancy of features based on combinatorial analysis of Lasso with application to lymphoma diagnosis

    Directory of Open Access Journals (Sweden)

    Zare Habil

    2013-01-01

    Full Text Available Abstract One challenge in applying bioinformatic tools to clinical or biological data is high number of features that might be provided to the learning algorithm without any prior knowledge on which ones should be used. In such applications, the number of features can drastically exceed the number of training instances which is often limited by the number of available samples for the study. The Lasso is one of many regularization methods that have been developed to prevent overfitting and improve prediction performance in high-dimensional settings. In this paper, we propose a novel algorithm for feature selection based on the Lasso and our hypothesis is that defining a scoring scheme that measures the "quality" of each feature can provide a more robust feature selection method. Our approach is to generate several samples from the training data by bootstrapping, determine the best relevance-ordering of the features for each sample, and finally combine these relevance-orderings to select highly relevant features. In addition to the theoretical analysis of our feature scoring scheme, we provided empirical evaluations on six real datasets from different fields to confirm the superiority of our method in exploratory data analysis and prediction performance. For example, we applied FeaLect, our feature scoring algorithm, to a lymphoma dataset, and according to a human expert, our method led to selecting more meaningful features than those commonly used in the clinics. This case study built a basis for discovering interesting new criteria for lymphoma diagnosis. Furthermore, to facilitate the use of our algorithm in other applications, the source code that implements our algorithm was released as FeaLect, a documented R package in CRAN.

  7. Evaluation of exome filtering techniques for the analysis of clinically relevant genes.

    Science.gov (United States)

    Kernohan, Kristin D; Hartley, Taila; Alirezaie, Najmeh; Robinson, Peter N; Dyment, David A; Boycott, Kym M

    2018-02-01

    A significant challenge facing clinical translation of exome sequencing is meaningful and efficient variant interpretation. Each exome contains ∼500 rare coding variants; laboratories must systematically and efficiently identify which variant(s) contribute to the patient's phenotype. In silico filtering is an approach that reduces analysis time while decreasing the chances of incidental findings. We retrospectively assessed 55 solved exomes using available datasets as in silico filters: Online Mendelian Inheritance in Man (OMIM), Orphanet, Human Phenotype Ontology (HPO), and Radboudumc University Medical Center curated panels. We found that personalized panels produced using HPO terms for each patient had the highest success rate (100%), while producing considerably less variants to assess. HPO panels also captured multiple diagnoses in the same individual. We conclude that custom HPO-derived panels are an efficient and effective way to identify clinically relevant exome variants. © 2017 Wiley Periodicals, Inc.

  8. Hypersensitivities for acetaldehyde and other agents among cancer cells null for clinically relevant Fanconi anemia genes.

    Science.gov (United States)

    Ghosh, Soma; Sur, Surojit; Yerram, Sashidhar R; Rago, Carlo; Bhunia, Anil K; Hossain, M Zulfiquer; Paun, Bogdan C; Ren, Yunzhao R; Iacobuzio-Donahue, Christine A; Azad, Nilofer A; Kern, Scott E

    2014-01-01

    Large-magnitude numerical distinctions (>10-fold) among drug responses of genetically contrasting cancers were crucial for guiding the development of some targeted therapies. Similar strategies brought epidemiological clues and prevention goals for genetic diseases. Such numerical guides, however, were incomplete or low magnitude for Fanconi anemia pathway (FANC) gene mutations relevant to cancer in FANC-mutation carriers (heterozygotes). We generated a four-gene FANC-null cancer panel, including the engineering of new PALB2/FANCN-null cancer cells by homologous recombination. A characteristic matching of FANCC-null, FANCG-null, BRCA2/FANCD1-null, and PALB2/FANCN-null phenotypes was confirmed by uniform tumor regression on single-dose cross-linker therapy in mice and by shared chemical hypersensitivities to various inter-strand cross-linking agents and γ-radiation in vitro. Some compounds, however, had contrasting magnitudes of sensitivity; a strikingly high (19- to 22-fold) hypersensitivity was seen among PALB2-null and BRCA2-null cells for the ethanol metabolite, acetaldehyde, associated with widespread chromosomal breakage at a concentration not producing breaks in parental cells. Because FANC-defective cancer cells can share or differ in their chemical sensitivities, patterns of selective hypersensitivity hold implications for the evolutionary understanding of this pathway. Clinical decisions for cancer-relevant prevention and management of FANC-mutation carriers could be modified by expanded studies of high-magnitude sensitivities. Copyright © 2014 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

  9. Descriptive study of the quality control in mammography

    International Nuclear Information System (INIS)

    Gaona, E.; Perdigon C, G.M.; Casian C, G.A.; Azorin N, J.; Diaz G, J.A.I.; Arreola, M.

    2005-01-01

    The goal of mammography is to provide contrast between a lesion that is possible residing within the breast and normal surrounding tissue. Quality control is essential for maintaining the contrast imaging performance of a mammography system and incorporate tests that are relevant in that they are predictive of future degradation of contrast imaging performance. These tests will also be done at frequency that is high enough to intercept most drifts in quality imaging or performance before they become diagnostically significant. The quality control study has as objective to describe the results of the assessment of quality imaging elements (film optical density, contrast (density difference), uniformity, resolution and noise) of 62 mammography departments without quality control program and comparison these results with a mammography reference department with a quality control program. When comparing the results they allow seeing the clinical utility of to have a quality control program to reduce the errors of mammography interpretation. (Author)

  10. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST).

    Science.gov (United States)

    de Souza, Jonas A; Yap, Bonnie J; Wroblewski, Kristen; Blinder, Victoria; Araújo, Fabiana S; Hlubocky, Fay J; Nicholas, Lauren H; O'Connor, Jeremy M; Brockstein, Bruce; Ratain, Mark J; Daugherty, Christopher K; Cella, David

    2017-02-01

    Cancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress. Patients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses. A total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r] = 0.28; Pfinancial toxicity were race (P = .04), employment status (Pcosts was not found to be associated with the degree of financial distress (P = .49). The COST measure demonstrated reliability and validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society. © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

  11. Zerodur polishing process for high surface quality and high efficiency

    International Nuclear Information System (INIS)

    Tesar, A.; Fuchs, B.

    1992-08-01

    Zerodur is a glass-ceramic composite importance in applications where temperature instabilities influence optical and mechanical performance, such as in earthbound and spaceborne telescope mirror substrates. Polished Zerodur surfaces of high quality have been required for laser gyro mirrors. Polished surface quality of substrates affects performance of high reflection coatings. Thus, the interest in improving Zerodur polished surface quality has become more general. Beyond eliminating subsurface damage, high quality surfaces are produced by reducing the amount of hydrated material redeposited on the surface during polishing. With the proper control of polishing parameters, such surfaces exhibit roughnesses of < l Angstrom rms. Zerodur polishing was studied to recommend a high surface quality polishing process which could be easily adapted to standard planetary continuous polishing machines and spindles. This summary contains information on a polishing process developed at LLNL which reproducibly provides high quality polished Zerodur surfaces at very high polishing efficiencies

  12. Status of reliability in determining SDDR for manual maintenance activities in ITER: Quality assessment of relevant activation cross sections involved

    International Nuclear Information System (INIS)

    Garcia, R.; Garcia, M.; Pampin, R.; Sanz, J.

    2016-01-01

    Highlights: • Feasibility of manual maintenance activities in ITER port cell and port interspace. • Activation of relevant materials and components placed in the current ITER model. • Dominant radionuclides and pathways for shutdown dose rate in ITER. • Quality analysis of typically used EAF and TENDL activation libraries is performed. • EAF performance found as trustworthy with slight recommended improvements. - Abstract: This paper assesses the quality of the EAF-2007 and 2010 activation cross sections for relevant reactions in the determination of the Shutdown Dose Rate (SDDR) in the Port Cell (PC) and Port Interspace (PI) areas of ITER. For each of relevant ITER materials, dominant radionuclides responsible of SDDR and their production pathways are listed. This information comes from a review of the recent reports/papers about SDDR in ITER and own calculations. A total of 26 relevant pathways are found. The quality of these cross sections pathways is assessed following EAF validation procedure, and for those found as not validated last TENDL library versions have been investigated in order to check possible improvements when compared to EAF. The use of EAF libraries is found as trustworthy and it is recommended for the prediction of SDDR in the ITER PC and PI. However, 3 cross section reactions are considered for further improvement: Co59(n,2n)Co58, Cu63(n,g)Cu64 and Cr50(n,g)Cr51.

  13. Status of reliability in determining SDDR for manual maintenance activities in ITER: Quality assessment of relevant activation cross sections involved

    Energy Technology Data Exchange (ETDEWEB)

    Garcia, R., E-mail: rgarciam@ind.uned.es [UNED, Power Engineering Department, C/Juan del Rosal 12, 28040 Madrid (Spain); Garcia, M. [UNED, Power Engineering Department, C/Juan del Rosal 12, 28040 Madrid (Spain); Pampin, R. [F4E, Torres Diagonal Litoral B3, Barcelona (Spain); Sanz, J. [UNED, Power Engineering Department, C/Juan del Rosal 12, 28040 Madrid (Spain)

    2016-11-15

    Highlights: • Feasibility of manual maintenance activities in ITER port cell and port interspace. • Activation of relevant materials and components placed in the current ITER model. • Dominant radionuclides and pathways for shutdown dose rate in ITER. • Quality analysis of typically used EAF and TENDL activation libraries is performed. • EAF performance found as trustworthy with slight recommended improvements. - Abstract: This paper assesses the quality of the EAF-2007 and 2010 activation cross sections for relevant reactions in the determination of the Shutdown Dose Rate (SDDR) in the Port Cell (PC) and Port Interspace (PI) areas of ITER. For each of relevant ITER materials, dominant radionuclides responsible of SDDR and their production pathways are listed. This information comes from a review of the recent reports/papers about SDDR in ITER and own calculations. A total of 26 relevant pathways are found. The quality of these cross sections pathways is assessed following EAF validation procedure, and for those found as not validated last TENDL library versions have been investigated in order to check possible improvements when compared to EAF. The use of EAF libraries is found as trustworthy and it is recommended for the prediction of SDDR in the ITER PC and PI. However, 3 cross section reactions are considered for further improvement: Co59(n,2n)Co58, Cu63(n,g)Cu64 and Cr50(n,g)Cr51.

  14. [Quality management is associated with high quality services in health care].

    Science.gov (United States)

    Nielsen, Tenna Hassert; Riis, Allan; Mainz, Jan; Jensen, Anne-Louise Degn

    2013-12-09

    In these years, quality management has been the focus in order to meet high quality services for the patients in Danish health care. This article provides information on quality management and quality improvement and it evaluates its effectiveness in achieving better organizational structures, processes and results in Danish health-care organizations. Our findings generally support that quality management is associated with high quality services in health care.

  15. Clinical quality needs complex adaptive systems and machine learning.

    Science.gov (United States)

    Marsland, Stephen; Buchan, Iain

    2004-01-01

    The vast increase in clinical data has the potential to bring about large improvements in clinical quality and other aspects of healthcare delivery. However, such benefits do not come without cost. The analysis of such large datasets, particularly where the data may have to be merged from several sources and may be noisy and incomplete, is a challenging task. Furthermore, the introduction of clinical changes is a cyclical task, meaning that the processes under examination operate in an environment that is not static. We suggest that traditional methods of analysis are unsuitable for the task, and identify complexity theory and machine learning as areas that have the potential to facilitate the examination of clinical quality. By its nature the field of complex adaptive systems deals with environments that change because of the interactions that have occurred in the past. We draw parallels between health informatics and bioinformatics, which has already started to successfully use machine learning methods.

  16. Organizational, technical, physical and clinical quality standards for radiotherapy

    Science.gov (United States)

    Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel

    2012-01-01

    Background Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters. Aim The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category. Materials and methods For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy. Results As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards. Conclusions Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:24377023

  17. Anxiety and quality of life: clinically anxious children with and without autism spectrum disorders compared

    NARCIS (Netherlands)

    van Steensel, F.J.A.; Bögels, S.M.; Dirksen, C.D.

    2012-01-01

    Comorbid anxiety disorders are common in children with autism spectrum disorders (ASD). However, studies comparing children with ASD to clinically anxious children are rare. This study investigated anxiety problems and health-related quality of life in children with high-functioning ASD and comorbid

  18. Delivering high quality hip fracture rehabilitation: the perspective of occupational and physical therapy practitioners.

    Science.gov (United States)

    Leland, Natalie E; Lepore, Michael; Wong, Carin; Chang, Sun Hwa; Freeman, Lynn; Crum, Karen; Gillies, Heather; Nash, Paul

    2018-03-01

    The majority of post-acute hip fracture rehabilitation in the US is delivered in skilled nursing facilities (SNFs). Currently, there are limited guidelines that equip occupational and physical therapy practitioners with a summary of what constitutes evidence-based high quality rehabilitation. Thus, this study aimed to identify rehabilitation practitioners' perspectives on the practices that constitute high quality hip fracture rehabilitation. Focus groups were conducted with 99 occupational and physical therapy practitioners working in SNFs in southern California. Purposive sampling of facilities was conducted to capture variation in key characteristics known to impact care delivery for this patient population (e.g., financial resources, staffing, and patient case-mix). Questions aimed to elicit practitioners' perspectives on high quality hip fracture rehabilitation practices. Each session was audio-recorded and transcribed. Data were systematically analyzed using a modified grounded theory approach. Seven themes emerged: objectives of care; first 72 h; positioning, pain, and precautions; use of standardized assessments; episode of care practices; facilitating insight into progress; and interdisciplinary collaboration. Clinical guidelines are critical tools to facilitate clinical decision-making and achieve desired patient outcomes. The findings of this study highlight the practitioners' perspective on what constitutes high quality hip fracture rehabilitation. This work provides critical information to advance the development of stakeholder-driven rehabilitation clinical guidelines. Future research is needed to verify the findings from other stakeholders (e.g., patients), ensure the alignment of our findings with current evidence, and develop measures for evaluating their delivery and relationship to desired outcomes. Implications for Rehabilitation This study highlights occupational and physiotherapy therapy practitioners' perspectives on the cumulative best

  19. Quality tools and resources to support organisational improvement integral to high-quality primary care: a systematic review of published and grey literature.

    Science.gov (United States)

    Janamian, Tina; Upham, Susan J; Crossland, Lisa; Jackson, Claire L

    2016-04-18

    To conduct a systematic review of the literature to identify existing online primary care quality improvement tools and resources to support organisational improvement related to the seven elements in the Primary Care Practice Improvement Tool (PC-PIT), with the identified tools and resources to progress to a Delphi study for further assessment of relevance and utility. Systematic review of the international published and grey literature. CINAHL, Embase and PubMed databases were searched in March 2014 for articles published between January 2004 and December 2013. GreyNet International and other relevant websites and repositories were also searched in March-April 2014 for documents dated between 1992 and 2012. All citations were imported into a bibliographic database. Published and unpublished tools and resources were included in the review if they were in English, related to primary care quality improvement and addressed any of the seven PC-PIT elements of a high-performing practice. Tools and resources that met the eligibility criteria were then evaluated for their accessibility, relevance, utility and comprehensiveness using a four-criteria appraisal framework. We used a data extraction template to systematically extract information from eligible tools and resources. A content analysis approach was used to explore the tools and resources and collate relevant information: name of the tool or resource, year and country of development, author, name of the organisation that provided access and its URL, accessibility information or problems, overview of each tool or resource and the quality improvement element(s) it addresses. If available, a copy of the tool or resource was downloaded into the bibliographic database, along with supporting evidence (published or unpublished) on its use in primary care. This systematic review identified 53 tools and resources that can potentially be provided as part of a suite of tools and resources to support primary care practices in

  20. Bridging existing governance gaps: five evidence-based actions that boards can take to pursue high quality care.

    Science.gov (United States)

    Leggat, Sandra G; Balding, Cathy

    2017-11-13

    Objective To explore the impact of the organisational quality systems on quality of care in Victorian health services. Methods During 2015 a total of 55 focus groups were conducted with more than 350 managers, clinical staff and board members in eight Victorian health services to explore the effectiveness of health service quality systems. A review of the quality and safety goals and strategies outlined in the strategic and operating plans of the participating health services was also undertaken. Results This paper focuses on the data related to the leadership role of health service boards in ensuring safe, high-quality care. The findings suggest that health service boards are not fully meeting their governance accountability to ensure consistently high-quality care. The data uncovered major clinical governance gaps between stated board and executive aspirations for quality and safety and the implementation of these expectations at point of care. These gaps were further compounded by quality system confusion, over-reliance on compliance, and inadequate staff engagement. Conclusion Based on the existing evidence we propose five specific actions boards can take to close the gaps, thereby supporting improved care for all consumers. What is known about this topic? Effective governance is essential for high-quality healthcare delivery. Boards are required to play an active role in their organisation's pursuit of high quality care. What does this paper add? Recent government reports suggest that Australian health service boards are not fully meeting their governance requirements for high quality, safe care delivery, and our research pinpoints key governance gaps. What are the implications for practitioners? Based on our research findings we outline five evidence-based actions for boards to improve their governance of quality care delivery. These actions focus on an organisational strategy for high-quality care, with the chief executive officer held accountable for

  1. Polanyi's tacit knowing and the relevance of epistemology to clinical medicine.

    Science.gov (United States)

    Henry, Stephen G

    2010-04-01

    Most clinicians take for granted a simple, reductionist understanding of medical knowledge that is at odds with how they actually practice medicine; routine medical decisions incorporate more complicated kinds of information than most standard accounts of medical reasoning suggest. A better understanding of the structure and function of knowledge in medicine can lead to practical improvements in clinical medicine. This understanding requires some familiarity with epistemology, the study of knowledge and its structure, in medicine. Michael Polanyi's theory of tacit knowing is advanced as the basis for developing a more accurate understanding of medical knowledge. Tacit knowing, which explores the taken-for-granted background knowledge that underlies all human knowing, is explained in detail with a focus on its relevance for clinical medicine. The implications of recognizing tacit knowing in medicine and medical decisions are discussed. These include the ability to explain the importance of the clinical encounter in medical practice, mechanisms for analysing patient and doctor as persons, and the need for humility given the uncertainty that the tacit dimension injects into all medical decisions. This more robust medical epistemology allows clinicians to better articulate the nature and importance of patient-centred care, to avoid pitfalls inherent in reductionist approaches to medical knowledge, and to think more clearly about the relationships between medicine and health care at the individual and population levels.

  2. A Bridge between Two Cultures: Uncovering the Chemistry Concepts Relevant to the Nursing Clinical Practice

    Science.gov (United States)

    Brown, Corina E.; Henry, Melissa L. M.; Barbera, Jack; Hyslop, Richard M.

    2012-01-01

    This study focused on the undergraduate course that covers basic topics in general, organic, and biological (GOB) chemistry at a mid-sized state university in the western United States. The central objective of the research was to identify the main topics of GOB chemistry relevant to the clinical practice of nursing. The collection of data was…

  3. A new quality of bone ultrasound research.

    Science.gov (United States)

    Gluer, C C

    2008-07-01

    Quantitative ultrasound (QUS) methods have strong power to predict osteoporotic fractures, but they are also very relevant for the assessment of bone quality. A representative sample of recent studies addressing these topics can be found in this special issue. Further pursuit of these methods will establish micro-QUS imaging methods as tools for measuring specific aspects of bone quality. Once this is achieved, we will be able to link such data to the clinical QUS methods used in vivo to determine which aspects of bone quality cause QUS to be a predictor of fracture risk that is independent of bone mineral density (BMD). Potentially this could lead to the development of a new generation of QUS devices for improved and expanded clinical assessment. Good quality of basic science work will thus lead to good quality of clinical patient examinations on the basis of a more detailed assessment of bone quality.

  4. Assessment of efficiency of functioning the infocommunication systems a special purpose in the conditions of violation quality of relevance information

    Science.gov (United States)

    Parinov, A. V.; Korotkikh, L. P.; Desyatov, D. B.; Stepanov, L. V.

    2018-03-01

    The uniqueness of information processing mechanisms in special-purpose infocommunication systems and the increased interest of intruders lead to an increase in the relevance of the problems associated with their protection. The paper considers the issues of building risk-models for the violation of the relevance and value of information in infocommunication systems for special purposes. Also, special attention is paid to the connection between the qualities of relevance and the value of information obtained as a result of the operation of infocommunication systems for special purposes. Analytical expressions for the risk and damage function in the time range in special-purpose infocommunication systems are obtained, which can serve as a mathematical basis for risk assessment. Further, an analytical expression is obtained to assess the chance of obtaining up-to-date information in the operation of infocommunication systems up to the time the information quality is violated. An analytical expression for estimating the chance can be used to calculate the effectiveness of a special-purpose infocommunication system.

  5. Teolenn: an efficient and customizable workflow to design high-quality probes for microarray experiments

    Science.gov (United States)

    Jourdren, Laurent; Duclos, Aurélie; Brion, Christian; Portnoy, Thomas; Mathis, Hugues; Margeot, Antoine; Le Crom, Stéphane

    2010-01-01

    Despite the development of new high-throughput sequencing techniques, microarrays are still attractive tools to study small genome organisms, thanks to sample multiplexing and high-feature densities. However, the oligonucleotide design remains a delicate step for most users. A vast array of software is available to deal with this problem, but each program is developed with its own strategy, which makes the choice of the best solution difficult. Here we describe Teolenn, a universal probe design workflow developed with a flexible and customizable module organization allowing fixed or variable length oligonucleotide generation. In addition, our software is able to supply quality scores for each of the designed probes. In order to assess the relevance of these scores, we performed a real hybridization using a tiling array designed against the Trichoderma reesei fungus genome. We show that our scoring pipeline correlates with signal quality for 97.2% of all the designed probes, allowing for a posteriori comparisons between quality scores and signal intensities. This result is useful in discarding any bad scoring probes during the design step in order to get high-quality microarrays. Teolenn is available at http://transcriptome.ens.fr/teolenn/. PMID:20176570

  6. Impact of Information Technology, Clinical Resource Constraints, and Patient-Centered Practice Characteristics on Quality of Care

    Directory of Open Access Journals (Sweden)

    JongDeuk Baek

    2015-02-01

    Full Text Available Objective: Factors in the practice environment, such as health information technology (IT infrastructure, availability of other clinical resources, and financial incentives, may influence whether practices are able to successfully implement the patient-centered medical home (PCMH model and realize its benefits. This study investigates the impacts of those PCMH-related elements on primary care physicians’ perception of quality of care. Methods: A multiple logistic regression model was estimated using the 2004 to 2005 CTS Physician Survey, a national sample of salaried primary care physicians (n = 1733. Results: The patient-centered practice environment and availability of clinical resources increased physicians’ perceived quality of care. Although IT use for clinical information access did enhance physicians’ ability to provide high quality of care, a similar positive impact of IT use was not found for e-prescribing or the exchange of clinical patient information. Lack of resources was negatively associated with physician perception of quality of care. Conclusion: Since health IT is an important foundation of PCMH, patient-centered practices are more likely to have health IT in place to support care delivery. However, despite its potential to enhance delivery of primary care, simply making health IT available does not necessarily translate into physicians’ perceptions that it enhances the quality of care they provide. It is critical for health-care managers and policy makers to ensure that primary care physicians fully recognize and embrace the use of new technology to improve both the quality of care provided and the patient outcomes.

  7. High-quality patents for emerging science and technology through external actors: Community scientific experts and knowledge societies

    NARCIS (Netherlands)

    Kica, Evisa; Groenendijk, Nico; Rodriguez, V.F.; Bonaccorsi, A.; Borras, S.

    2010-01-01

    This article explores one type of administrative mechanism to achieve high-quality patents: Article 115 of the European Patent Convention, which permits the inclusion of third parties to provide input to the prior art search and to communicate relevant information to the examiner in charge. Our

  8. Relevance of motion-related assessment metrics in laparoscopic surgery.

    Science.gov (United States)

    Oropesa, Ignacio; Chmarra, Magdalena K; Sánchez-González, Patricia; Lamata, Pablo; Rodrigues, Sharon P; Enciso, Silvia; Sánchez-Margallo, Francisco M; Jansen, Frank-Willem; Dankelman, Jenny; Gómez, Enrique J

    2013-06-01

    Motion metrics have become an important source of information when addressing the assessment of surgical expertise. However, their direct relationship with the different surgical skills has not been fully explored. The purpose of this study is to investigate the relevance of motion-related metrics in the evaluation processes of basic psychomotor laparoscopic skills and their correlation with the different abilities sought to measure. A framework for task definition and metric analysis is proposed. An explorative survey was first conducted with a board of experts to identify metrics to assess basic psychomotor skills. Based on the output of that survey, 3 novel tasks for surgical assessment were designed. Face and construct validation was performed, with focus on motion-related metrics. Tasks were performed by 42 participants (16 novices, 22 residents, and 4 experts). Movements of the laparoscopic instruments were registered with the TrEndo tracking system and analyzed. Time, path length, and depth showed construct validity for all 3 tasks. Motion smoothness and idle time also showed validity for tasks involving bimanual coordination and tasks requiring a more tactical approach, respectively. Additionally, motion smoothness and average speed showed a high internal consistency, proving them to be the most task-independent of all the metrics analyzed. Motion metrics are complementary and valid for assessing basic psychomotor skills, and their relevance depends on the skill being evaluated. A larger clinical implementation, combined with quality performance information, will give more insight on the relevance of the results shown in this study.

  9. Detection of Adriamycin-DNA adducts by accelerator mass spectrometry at clinically relevant Adriamycin concentrations.

    Science.gov (United States)

    Coldwell, Kate E; Cutts, Suzanne M; Ognibene, Ted J; Henderson, Paul T; Phillips, Don R

    2008-09-01

    Limited sensitivity of existing assays has prevented investigation of whether Adriamycin-DNA adducts are involved in the anti-tumour potential of Adriamycin. Previous detection has achieved a sensitivity of a few Adriamycin-DNA adducts/10(4) bp DNA, but has required the use of supra-clinical drug concentrations. This work sought to measure Adriamycin-DNA adducts at sub-micromolar doses using accelerator mass spectrometry (AMS), a technique with origins in geochemistry for radiocarbon dating. We have used conditions previously validated (by less sensitive decay counting) to extract [(14)C]Adriamycin-DNA adducts from cells and adapted the methodology to AMS detection. Here we show the first direct evidence of Adriamycin-DNA adducts at clinically-relevant Adriamycin concentrations. [(14)C]Adriamycin treatment (25 nM) resulted in 4.4 +/- 1.0 adducts/10(7) bp ( approximately 1300 adducts/cell) in MCF-7 breast cancer cells, representing the best sensitivity and precision reported to date for the covalent binding of Adriamycin to DNA. The exceedingly sensitive nature of AMS has enabled over three orders of magnitude increased sensitivity of Adriamycin-DNA adduct detection and revealed adduct formation within an hour of drug treatment. This method has been shown to be highly reproducible for the measurement of Adriamycin-DNA adducts in tumour cells in culture and can now be applied to the detection of these adducts in human tissues.

  10. Using language models to identify relevant new information in inpatient clinical notes.

    Science.gov (United States)

    Zhang, Rui; Pakhomov, Serguei V; Lee, Janet T; Melton, Genevieve B

    2014-01-01

    Redundant information in clinical notes within electronic health record (EHR) systems is ubiquitous and may negatively impact the use of these notes by clinicians, and, potentially, the efficiency of patient care delivery. Automated methods to identify redundant versus relevant new information may provide a valuable tool for clinicians to better synthesize patient information and navigate to clinically important details. In this study, we investigated the use of language models for identification of new information in inpatient notes, and evaluated our methods using expert-derived reference standards. The best method achieved precision of 0.743, recall of 0.832 and F1-measure of 0.784. The average proportion of redundant information was similar between inpatient and outpatient progress notes (76.6% (SD=17.3%) and 76.7% (SD=14.0%), respectively). Advanced practice providers tended to have higher rates of redundancy in their notes compared to physicians. Future investigation includes the addition of semantic components and visualization of new information.

  11. Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

    Science.gov (United States)

    Motte, Anne-France; Diallo, Stéphanie; van den Brink, Hélène; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, Pierre; Cour, Florence; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas

    2017-11-01

    The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Fungal-bacterial interactions and their relevance to oral health: linking the clinic and the bench.

    Science.gov (United States)

    Diaz, Patricia I; Strausbaugh, Linda D; Dongari-Bagtzoglou, Anna

    2014-01-01

    High throughput sequencing has accelerated knowledge on the oral microbiome. While the bacterial component of oral communities has been extensively characterized, the role of the fungal microbiota in the oral cavity is largely unknown. Interactions among fungi and bacteria are likely to influence oral health as exemplified by the synergistic relationship between Candida albicans and oral streptococci. In this perspective, we discuss the current state of the field of fungal-bacterial interactions in the context of the oral cavity. We highlight the need to conduct longitudinal clinical studies to simultaneously characterize the bacterial and fungal components of the human oral microbiome in health and during disease progression. Such studies need to be coupled with investigations using disease-relevant models to mechanistically test the associations observed in humans and eventually identify fungal-bacterial interactions that could serve as preventive or therapeutic targets for oral diseases.

  13. Fungal-bacterial interactions and their relevance to oral health: linking the clinic and the bench

    Directory of Open Access Journals (Sweden)

    Patricia I Diaz

    2014-07-01

    Full Text Available High throughput sequencing has accelerated knowledge on the oral microbiome. While the bacterial component of oral communities has been extensively characterized, the role of the fungal microbiota in the oral cavity is largely unknown. Interactions among fungi and bacteria are likely to influence oral health as exemplified by the synergistic relationship between Candida albicans and oral streptococci. In this perspective, we discuss the current state of the field of fungal-bacterial interactions in the context of the oral cavity. We highlight the need to conduct longitudinal clinical studies to simultaneously characterize the bacterial and fungal components of the human oral microbiome in health and during disease progression. Such studies need to be coupled with investigations using disease-relevant models to mechanistically test the associations observed in humans and eventually identify fungal-bacterial interactions that could serve as preventive or therapeutic targets for oral diseases.

  14. The relevance of "non-relevant metabolites" from plant protection products (PPPs) for drinking water: the German view.

    Science.gov (United States)

    Dieter, Hermann H

    2010-03-01

    "Non-relevant metabolites" are those degradation products of plant protection products (PPPs), which are devoid of the targeted toxicities of the PPP and devoid of genotoxicity. Most often, "non-relevant metabolites" have a high affinity to the aquatic environment, are very mobile within this environment, and, usually, are also persistent. Therefore, from the point of drinking water hygiene, they must be characterized as "relevant for drinking water" like many other hydrophilic/polar environmental contaminants of different origins. "Non-relevant metabolites" may therefore penetrate to water sources used for abstraction of drinking water and may thus ultimately be present in drinking water. The presence of "non-relevant metabolites" and similar trace compounds in the water cycle may endanger drinking water quality on a long-term scale. During oxidative drinking water treatment, "non-relevant metabolites" may also serve as the starting material for toxicologically relevant transformation products similar to processes observed by drinking water disinfection with chlorine. This hypothesis was recently confirmed by the detection of the formation of N-nitroso-dimethylamine from ozone and dimethylsulfamide, a "non-relevant metabolite" of the fungicide tolylfluanide. In order to keep drinking water preferably free of "non-relevant metabolites", the German drinking water advisory board of the Federal Ministry of Health supports limiting their penetration into raw and drinking water to the functionally (agriculturally) unavoidable extent. On this background, the German Federal Environment Agency (UBA) recently has recommended two health related indication values (HRIV) to assess "non-relevant metabolites" from the view of drinking water hygiene. Considering the sometimes incomplete toxicological data base for some "non-relevant metabolites", HRIV also have the role of health related precautionary values. Depending on the completeness and quality of the toxicological

  15. Has compliance with CLIA requirements really improved quality in US clinical laboratories?

    Science.gov (United States)

    Ehrmeyer, Sharon S; Laessig, Ronald H

    2004-08-02

    The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

  16. The interaction between sleep quality and academic performance.

    Science.gov (United States)

    Ahrberg, K; Dresler, M; Niedermaier, S; Steiger, A; Genzel, L

    2012-12-01

    Sleep quality has significant effects on cognitive performance and is influenced by multiple factors such as stress. Contrary to the ideal, medical students and residents suffer from sleep deprivation and stress at times when they should achieve the greatest amount of learning. In order to examine the relationship between sleep quality and academic performance, 144 medical students undertaking the pre-clinical board exam answered a survey regarding their subjective sleep quality (Pittsburgh sleep quality index, PSQI), grades and subjective stress for three different time points: semester, pre- and post-exam. Academic performance correlated with stress and sleep quality pre-exam (r = 0.276, p quality and high stress), however not with the stress or sleep quality during the semester and post-exam. 59% of all participants exhibited clinically relevant sleep disturbances (PSQI > 5) during exam preparation compared to 29% during the semester and 8% post-exam. This study shows that in medical students it is not the generally poor sleepers, who perform worse in the medical board exams. Instead students who will perform worse on their exams seem to be more stressed and suffer from poor sleep quality. However, poor sleep quality may negatively impact test performance as well, creating a vicious circle. Furthermore, the rate of sleep disturbances in medical students should be cause for intervention. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms.

    Science.gov (United States)

    Hermans, Andre; Abend, Andreas M; Kesisoglou, Filippos; Flanagan, Talia; Cohen, Michael J; Diaz, Dorys A; Mao, Y; Zhang, Limin; Webster, Gregory K; Lin, Yiqing; Hahn, David A; Coutant, Carrie A; Grady, Haiyan

    2017-11-01

    This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the development of CRS for IR products containing active ingredients with a non-narrow therapeutic window is discussed, within the context of mechanistic dissolution understanding, supported by in-human pharmacokinetic (PK) data. Two case studies present potential outcomes of following the CRS roadmap and setting dissolution specifications. These cases reveal some benefits and challenges of pursuing CRS with additional PK data, in light of current regulatory positions, including that of the US Food and Drug Administration (FDA), who generally favor this approach, but with the understanding that both industry and regulatory agency perspectives are still evolving in this relatively new field. The CRS roadmap discussed in this manuscript also describes a way to develop clinically relevant dissolution specifications based primarily on dissolution data for batches used in pivotal clinical studies, acknowledging that not all IR product development efforts need to be supported by additional PK studies, albeit with the associated risk of potentially unnecessarily tight manufacturing controls. Recommendations are provided on what stages during the life cycle investment into in vivo studies may be valuable. Finally, the opportunities for CRS within the context of post-approval changes, Modeling and Simulation (M&S), and the application of biowaivers, are briefly discussed.

  18. Beyond clinical engagement: a pragmatic model for quality improvement interventions, aligning clinical and managerial priorities.

    Science.gov (United States)

    Pannick, Samuel; Sevdalis, Nick; Athanasiou, Thanos

    2016-09-01

    Despite taking advantage of established learning from other industries, quality improvement initiatives in healthcare may struggle to outperform secular trends. The reasons for this are rarely explored in detail, and are often attributed merely to difficulties in engaging clinicians in quality improvement work. In a narrative review of the literature, we argue that this focus on clinicians, at the relative expense of managerial staff, has proven counterproductive. Clinical engagement is not a universal challenge; moreover, there is evidence that managers-particularly middle managers-also have a role to play in quality improvement. Yet managerial participation in quality improvement interventions is often assumed, rather than proven. We identify specific factors that influence the coordination of front-line staff and managers in quality improvement, and integrate these factors into a novel model: the model of alignment. We use this model to explore the implementation of an interdisciplinary intervention in a recent trial, describing different participation incentives and barriers for different staff groups. The extent to which clinical and managerial interests align may be an important determinant of the ultimate success of quality improvement interventions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  19. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

    Directory of Open Access Journals (Sweden)

    Ziningi Jaya

    Full Text Available Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC clinics in rural KwaZulu-Natal (KZN, South Africa.We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor. A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05.Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2% of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged

  20. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

    Science.gov (United States)

    Jaya, Ziningi; Drain, Paul K; Mashamba-Thompson, Tivani P

    2017-01-01

    Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged between 64.4% (CI

  1. Clinically relevant diagnostic research in primary care: the example of B-type natriuretic peptides in the detection of heart failure.

    Science.gov (United States)

    Kelder, Johannes C; Rutten, Frans H; Hoes, Arno W

    2009-02-01

    With the emergence of novel diagnostic tests, e.g. point-of-care tests, clinically relevant empirical evidence is needed to assess whether such a test should be used in daily practice. With the example of the value of B-type natriuretic peptides (BNP) in the diagnostic assessment of suspected heart failure, we will discuss the major methodological issues crucial in diagnostic research; most notably the choice of the study population and the data analysis with a multivariable approach. BNP have been studied extensively in the emergency care setting, and also several studies in the primary care are available. The usefulness of this test when applied in combination with other readily available tests is still not adequately addressed in the relevant patient domain, i.e. those who are clinically suspected of heart failure by their GP. Future diagnostic research in primary care should be targeted much more at answering the clinically relevant question 'Is it useful to add this (new) test to the other tests I usually perform, including history taking and physical examination, in patients I suspect of having a certain disease'.

  2. Quality assurance requirements and methods for high level waste package acceptability

    International Nuclear Information System (INIS)

    1992-12-01

    This document should serve as guidance for assigning the necessary items to control the conditioning process in such a way that waste packages are produced in compliance with the waste acceptance requirements. It is also provided to promote the exchange of information on quality assurance requirements and on the application of quality assurance methods associated with the production of high level waste packages, to ensure that these waste packages comply with the requirements for transportation, interim storage and waste disposal in deep geological formations. The document is intended to assist both the operators of conditioning facilities and repositories as well as national authorities and regulatory bodies, involved in the licensing of the conditioning of high level radioactive wastes or in the development of deep underground disposal systems. The document recommends the quality assurance requirements and methods which are necessary to generate data for these parameters identified in IAEA-TECDOC-560 on qualitative acceptance criteria, and indicates where and when the control methods can be applied, e.g. in the operation or commissioning of a process or in the development of a waste package design. Emphasis is on the control of the process and little reliance is placed on non-destructive or destructive testing. Qualitative criteria, relevant to disposal of high level waste, are repository dependent and are not addressed here. 37 refs, 3 figs, 2 tabs

  3. A guide to calculating habitat-quality metrics to inform conservation of highly mobile species

    Science.gov (United States)

    Bieri, Joanna A.; Sample, Christine; Thogmartin, Wayne E.; Diffendorfer, James E.; Earl, Julia E.; Erickson, Richard A.; Federico, Paula; Flockhart, D. T. Tyler; Nicol, Sam; Semmens, Darius J.; Skraber, T.; Wiederholt, Ruscena; Mattsson, Brady J.

    2018-01-01

    Many metrics exist for quantifying the relative value of habitats and pathways used by highly mobile species. Properly selecting and applying such metrics requires substantial background in mathematics and understanding the relevant management arena. To address this multidimensional challenge, we demonstrate and compare three measurements of habitat quality: graph-, occupancy-, and demographic-based metrics. Each metric provides insights into system dynamics, at the expense of increasing amounts and complexity of data and models. Our descriptions and comparisons of diverse habitat-quality metrics provide means for practitioners to overcome the modeling challenges associated with management or conservation of such highly mobile species. Whereas previous guidance for applying habitat-quality metrics has been scattered in diversified tracks of literature, we have brought this information together into an approachable format including accessible descriptions and a modeling case study for a typical example that conservation professionals can adapt for their own decision contexts and focal populations.Considerations for Resource ManagersManagement objectives, proposed actions, data availability and quality, and model assumptions are all relevant considerations when applying and interpreting habitat-quality metrics.Graph-based metrics answer questions related to habitat centrality and connectivity, are suitable for populations with any movement pattern, quantify basic spatial and temporal patterns of occupancy and movement, and require the least data.Occupancy-based metrics answer questions about likelihood of persistence or colonization, are suitable for populations that undergo localized extinctions, quantify spatial and temporal patterns of occupancy and movement, and require a moderate amount of data.Demographic-based metrics answer questions about relative or absolute population size, are suitable for populations with any movement pattern, quantify demographic

  4. Standardized manual palpation of myofascial trigger points in relation to neck/shoulder pain; the influence of clinical experience on inter-examiner reproducibility

    DEFF Research Database (Denmark)

    Myburgh, Corrie; Lauridsen, Henrik Hein; Larsen, Anders H

    2011-01-01

    A diagnosis of Myofascial Pain Syndrome (MPS) requires palpation for the identification of at least one clinically relevant trigger point (TP). However, few comparable, high quality studies currently exist from which to draw firm conclusions regarding the robustness of TP examination. An inter-ob...

  5. User perspectives on relevance criteria

    DEFF Research Database (Denmark)

    Maglaughlin, Kelly L.; Sonnenwald, Diane H.

    2002-01-01

    , partially relevant, or not relevant to their information need; and explained their decisions in an interview. Analysis revealed 29 criteria, discussed positively and negatively, that were used by the participants when selecting passages that contributed or detracted from a document's relevance......This study investigates the use of criteria to assess relevant, partially relevant, and not-relevant documents. Study participants identified passages within 20 document representations that they used to make relevance judgments; judged each document representation as a whole to be relevant...... matter, thought catalyst), full text (e.g., audience, novelty, type, possible content, utility), journal/publisher (e.g., novelty, main focus, perceived quality), and personal (e.g., competition, time requirements). Results further indicate that multiple criteria are used when making relevant, partially...

  6. Sleep quantity, quality, and insomnia symptoms of medical students during clinical years. Relationship with stress and academic performance

    Directory of Open Access Journals (Sweden)

    Mohammed A. Alsaggaf

    2016-02-01

    Full Text Available Objectives: To determine sleep habits and sleep quality in medical students during their clinical years using validated measures; and to investigate associations with academic performance and psychological stress. Methods: In this cross-sectional study, medical students (n=320 were randomly selected from a list of all enrolled clinical-year students in a Saudi medical school from 2011-2012. Students filled a questionnaire including demographic and lifestyle factors, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and Perceived Stress Scale. Results: Students acquired on average, 5.8 hours of sleep each night, with an average bedtime at 01:53. Approximately 8% reported acquiring sleep during the day, and not during nighttime. Poor sleep quality was present in 30%, excessive daytime sleepiness (EDS in 40%, and insomnia symptoms in 33% of students. Multivariable regression models revealed significant associations between stress, poor sleep quality, and EDS. Poorer academic performance and stress were associated with symptoms of insomnia. Conclusion: Sleep deprivation, poor sleep quality, and EDS are common among clinical years medical students. High levels of stress and the pressure of maintaining grade point averages may be influencing their quality of sleep.

  7. Biomarkers for Early Detection of Clinically Relevant Prostate Cancer. A Multi-Institutional Validation Trial

    Science.gov (United States)

    2016-10-01

    aim 2: Evaluate a panel of four-kallikrein plasma-based markers to determine the presence of or progression to clinically relevant prostate cancer...and sent to Genomic Health, Inc. for processing. Task 3: Analysis of scientific Aim 2: Evaluate a panel of four-kallikrein plasma-based markers to...site: FHCRC) PCA3 and the TMPRSS2:ERG fusion are prostate cancer-specific biomarkers that hold promise for stratifying risk in the setting of AS

  8. Time-driven activity-based costing in an outpatient clinic environment: development, relevance and managerial impact.

    Science.gov (United States)

    Demeere, Nathalie; Stouthuysen, Kristof; Roodhooft, Filip

    2009-10-01

    Healthcare managers are continuously urged to provide better patient services at a lower cost. To cope with these cost pressures, healthcare management needs to improve its understanding of the relevant cost drivers. Through a case study, we show how to perform a time-driven activity-based costing of five outpatient clinic's departments and provide evidence of the benefits of such an analysis.

  9. Quality Improvement of Clinical Handover in a Liaison Psychiatry Department: A Three-Phase Audit

    LENUS (Irish Health Repository)

    Alexander, L

    2018-06-01

    Clinical handover has been identified as a period of high risk in healthcare, with increased incidence of adverse outcomes and near-misses. The purpose of handover is to communicate relevant information between medical professionals, with emphasis on completing management tasks and preventing patients from ‘falling through the cracks’1. Poor handover practices contribute to catastrophic but avoidable adverse events in healthcare. In Ireland, one such high profile incident has been a particular catalyst in the development of comprehensive handover guidelines in maternity settings2. Other specialities have yet to follow suit and there remains a dearth of guidance on handover practices, particularly guidance that can be applied to highly specialised and logistically unique areas, such as psychiatry

  10. Covalent immobilisation of antibodies in Teflon-FEP microfluidic devices for the sensitive quantification of clinically relevant protein biomarkers.

    Science.gov (United States)

    Pivetal, Jeremy; Pereira, Filipa M; Barbosa, Ana I; Castanheira, Ana P; Reis, Nuno M; Edwards, Alexander D

    2017-03-13

    This study reports for the first time the sensitive colorimetric and fluorescence detection of clinically relevant protein biomarkers by sandwich immunoassays using the covalent immobilisation of antibodies onto the fluoropolymer surface inside Teflon®-FEP microfluidic devices. Teflon®-FEP has outstanding optical transparency ideal for high-sensitivity colorimetric and fluorescence bioassays, however this thermoplastic is regarded as chemically inert and very hydrophobic. Covalent immobilisation can offer benefits over passive adsorption to plastic surfaces by allowing better control over antibody density, orientation and analyte binding capacity, and so we tested a range of different and novel covalent immobilisation strategies. We first functionalised the inner surface of a 10-bore, 200 μm internal diameter FEP microcapillary film with high-molecular weight polyvinyl alcohol (PVOH) without changing the outstanding optical transparency of the device delivered by the matched refractive index of FEP and water. Glutaraldehyde immobilisation was compared with the use of photoactivated linkers and NHS-ester crosslinkers for covalently immobilising capture antibodies onto PVOH. Three clinically relevant sandwich ELISAs were tested against the cytokine IL-1β, the myocardial infarct marker cardiac troponin I (cTnI), and the chronic heart failure marker brain natriuretic peptide (BNP). Overall, glutaraldehyde immobilisation was effective for BNP assays, but yielded unacceptable background for IL-1β and cTnI assays caused by direct binding of the biotinylated detection antibody to the modified PVOH surface. We found NHS-ester groups reacted with APTES-treated PVOH coated fluoropolymers. This facilitated a novel method for capture antibody immobilisation onto fluoropolymer devices using a bifunctional NHS-maleimide crosslinker. The density of covalently immobilised capture antibodies achieved using PVOH/APTES/NHS/maleimide approached levels seen with passive adsorption

  11. Clinically relevant pain relief with an ibuprofen-releasing foam dressing

    DEFF Research Database (Denmark)

    Fogh, Karsten; Andersen, Maibritt B; Bischoff-Mikkelsen, Morten

    2012-01-01

    The objective of this 6-week, 120-patient, double-blind, randomized, controlled trial was to investigate if a foam dressing with ibuprofen provided clinically relevant pain relief (PAR) for exuding, painful venous leg ulcers in comparison with a similar foam dressing without ibuprofen. Primary......) and the corresponding number needed to treat (NNT). Wound-related parameters such as ulcer healing, ulcer area reduction, and peri-ulcer skin condition as well as adverse events were recorded during all 6 weeks of the investigation. PAR was significantly greater in the ibuprofen foam group than the comparator group (p...... = 0.0438). There were 34% responders in the ibuprofen foam group vs. 19% in the comparator group (NNT = 6.8). When evening data were analyzed separately to evaluate PAR over daytime, NNT was 5.3. Wound healing parameters and adverse events were comparable. In conclusion, in this study, the ibuprofen...

  12. Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

    Science.gov (United States)

    Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

    2011-06-01

    To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

  13. Dose-dependent cytotoxicity of clinically relevant cobalt nanoparticles and ions on macrophages in vitro

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Young-Min; Xia Zhidao; Glyn-Jones, Sion; Beard, David; Gill, Harinderjit S; Murray, David W, E-mail: young-min.kwon@ndos.ox.ac.u [Nuffield Department of Orthopaedic Surgery, University of Oxford, Oxford OX3 7LD (United Kingdom)

    2009-04-15

    Despite the satisfactory short-term implant survivorship of metal-on-metal hip resurfacing arthroplasty, periprosthetic soft-tissue masses such as pseudotumours are being increasingly reported. Cytotoxic effects of cobalt or chromium have been suggested to play a role in its aetiology. The aim of this study was to investigate the effects of clinically relevant metal nanoparticles and ions on the viability of macrophages in vitro. A RAW 264.7 murine macrophage cell line was cultured in the presence of either: (1) cobalt, chromium and titanium nanoparticles sized 30-35 nm; or (2) cobalt sulphate and chromium chloride. Two methods were used to quantify cell viability: Alamar Blue assay and Live/Dead assay. The cytotoxicity was observed only with cobalt. Cobalt nanoparticles and ions demonstrated dose-dependent cytotoxic effects on macrophages in vitro: the cytotoxic concentrations of nanoparticles and ions were 1 x 10{sup 12} particles ml{sup -1} and 1000 {mu}M, respectively. The high concentration of cobalt nanoparticles required for cytotoxicity of macrophages in vitro suggests that increased production of cobalt nanoparticles in vivo, due to excessive MoM implant wear, may lead to local adverse biological effects. Therefore, cytotoxicity of high concentrations of metal nanoparticles phagocytosed by macrophages located in the periprosthetic tissues may be an important factor in pathogenesis of pseudotumours.

  14. Promoting culturally competent chronic pain management using the clinically relevant continuum model.

    Science.gov (United States)

    Monsivais, Diane B

    2011-06-01

    This article reviews the culture of biomedicine and current practices in pain management education, which often merge to create a hostile environment for effective chronic pain care. Areas of cultural tensions in chronic pain frequently involve the struggle to achieve credibility regarding one's complaints of pain (or being believed that the pain is real) and complying with pain medication protocols. The clinically relevant continuum model is presented as a framework allowing providers to approach care from an evidence-based, culturally appropriate (patient centered) perspective that takes into account the highest level of evidence available, provider expertise, and patient preferences and values. Copyright © 2011 Elsevier Inc. All rights reserved.

  15. A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

    Science.gov (United States)

    Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

    2014-12-01

    A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

  16. Multimodal imaging of bone metastases: From preclinical to clinical applications

    Directory of Open Access Journals (Sweden)

    Stephan Ellmann

    2015-10-01

    Full Text Available Metastases to the skeletal system are commonly observed in cancer patients, highly affecting the patients' quality of life. Imaging plays a major role in detection, follow-up, and molecular characterisation of metastatic disease. Thus, imaging techniques have been optimised and combined in a multimodal and multiparametric manner for assessment of complementary aspects in osseous metastases. This review summarises both application of the most relevant imaging techniques for bone metastasis in preclinical models and the clinical setting.

  17. Personality and Relationship Quality During the Transition From High School to Early Adulthood

    Science.gov (United States)

    Parker, Philip D.; Lüdtke, Oliver; Trautwein, Ulrich; Roberts, Brent W.

    2013-01-01

    The post–high school transition period is believed to be associated with considerable changes in social networks, yet longitudinal studies documenting these changes are scarce. To address this gap, the current research explored 3 relevant issues. First, changes in participants’ relationship characteristics during the transition from high school were examined. Second, the roles of personality traits as antecedents of these changes were studied. Third, the association between change in relationship characteristics and personality during the transition was explored. A sample of over 2,000 German emerging adults, surveyed before leaving school and then 2 years after the transition from high school, was assessed on personality traits and a multidimensional assessment of the quality of their relationships. Findings indicated that participants experienced mostly positive changes in relationship quality during the transition from high school and that antecedent personality at school was an important predictor of the nature of this change. Finally, change in relationship quality was found to be associated with personality change during the post-school transition. Findings indicated that personality traits may influence transition success and that change in relationships during this transition may influence personality development. The implications of the research for post-school transition success are discussed. PMID:22224909

  18. Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

    Science.gov (United States)

    de Carvalho, Elias Cesar Araujo; Batilana, Adelia Portero; Claudino, Wederson; Reis, Luiz Fernando Lima; Schmerling, Rafael A; Shah, Jatin; Pietrobon, Ricardo

    2012-01-01

    With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial

  19. Service quality and clinical outcomes: an example from mental health rehabilitation services in England.

    Science.gov (United States)

    Killaspy, Helen; Marston, Louise; Omar, Rumana Z; Green, Nicholas; Harrison, Isobel; Lean, Melanie; Holloway, Frank; Craig, Tom; Leavey, Gerard; King, Michael

    2013-01-01

    Current health policy assumes better quality services lead to better outcomes. To investigate the relationship between quality of mental health rehabilitation services in England, local deprivation, service user characteristics and clinical outcomes. Standardised tools were used to assess the quality of mental health rehabilitation units and service users' autonomy, quality of life, experiences of care and ratings of the therapeutic milieu. Multiple level modelling investigated relationships between service quality, service user characteristics and outcomes. A total of 52/60 (87%) National Health Service trusts participated, comprising 133 units and 739 service users. All aspects of service quality were positively associated with service users' autonomy, experiences of care and therapeutic milieu, but there was no association with quality of life. Quality of care is linked to better clinical outcomes in people with complex and longer-term mental health problems. Thus, investing in quality is likely to show real clinical gains.

  20. Impact of a structured template and staff training on compliance and quality of clinical handover.

    Science.gov (United States)

    Ahmed, J; Mehmood, S; Rehman, S; Ilyas, C; Khan, L U R

    2012-01-01

    Change in junior doctors working pattern has brought effective and safe clinical handover into a central role to ensure the patient safety and high quality care. We investigated whether the compliance and quality of clinical handover could be improved through the use of a standardised and structured handover template. A computerised template was developed in accordance with handover guidelines provided by the Royal College of Surgeons of England. Pre- and post-intervention audits against an eleven-point dataset pertaining to the handover of acute surgical admissions were undertaken. The results from the two discrete audits periods were compared to examine the impact of intervention. There were 137 acute surgical admissions during pre-intervention and 155 admissions in post-intervention audit period. A significant improvement in overall handover practice was observed in post-intervention period. The documentation of patient hospital number (84 (61%) vs. 132 (85%) pimportance of safe clinical handover among the junior doctors. Implementation of a standardised guideline-based structured handover template and training of junior doctors are likely to improve compliance to agreed standards, promote quality of care, and protect patient safety. Copyright © 2012 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  1. Low-cost, high-resolution scanning laser ophthalmoscope for the clinical environment

    Science.gov (United States)

    Soliz, P.; Larichev, A.; Zamora, G.; Murillo, S.; Barriga, E. S.

    2010-02-01

    Researchers have sought to gain greater insight into the mechanisms of the retina and the optic disc at high spatial resolutions that would enable the visualization of small structures such as photoreceptors and nerve fiber bundles. The sources of retinal image quality degradation are aberrations within the human eye, which limit the achievable resolution and the contrast of small image details. To overcome these fundamental limitations, researchers have been applying adaptive optics (AO) techniques to correct for the aberrations. Today, deformable mirror based adaptive optics devices have been developed to overcome the limitations of standard fundus cameras, but at prices that are typically unaffordable for most clinics. In this paper we demonstrate a clinically viable fundus camera with auto-focus and astigmatism correction that is easy to use and has improved resolution. We have shown that removal of low-order aberrations results in significantly better resolution and quality images. Additionally, through the application of image restoration and super-resolution techniques, the images present considerably improved quality. The improvements lead to enhanced visualization of retinal structures associated with pathology.

  2. Clinical Relevance of 18F-Sodium Fluoride Positron-Emission Tomography in Noninvasive Identification of High-Risk Plaque in Patients With Coronary Artery Disease.

    Science.gov (United States)

    Lee, Joo Myung; Bang, Ji-In; Koo, Bon-Kwon; Hwang, Doyeon; Park, Jonghanne; Zhang, Jinlong; Yaliang, Tong; Suh, Minseok; Paeng, Jin Chul; Shiono, Yasutsugu; Kubo, Takashi; Akasaka, Takashi

    2017-11-01

    18 F-sodium fluoride ( 18 F-NaF) positron-emission tomography has been introduced as a potential noninvasive imaging tool to identify plaques with high-risk characteristics in patients with coronary artery disease. We sought to evaluate the clinical relevance of 18 F-NaF uptake using optical coherence tomography (OCT), intravascular ultrasound (IVUS), and coronary computed tomography angiography in patients with coronary artery disease. The target population consisted of 51 prospectively enrolled patients (93 stenoses) who underwent 18 F-NaF positron-emission tomography before invasive coronary angiography. 18 F-NaF uptake was compared with IVUS- and OCT-derived plaque characteristics. In the coronary computed tomography angiography subgroup (46 lesions), qualitative lesion characteristics were compared between 18 F-NaF-positive and 18 F-NaF-negative plaques using adverse plaque characteristics. The plaques with 18 F-NaF uptake showed significantly higher plaque burden, more frequent posterior attenuation and positive remodeling in IVUS, and significantly higher maximum lipid arc and more frequent microvessels in OCT (all P characteristics. The 18 F-NaF tissue-to-background ratio in plaques with high-risk characteristics was significantly higher than in those without (1.09 [95% confidence interval, 0.85-1.34] versus 0.62 [95% confidence interval, 0.42-0.82], P characteristics between 18 F-NaF-positive and 18 F-NaF-negative plaques in the coronary computed tomography angiography subgroup (85.2% versus 78.9%; P =0.583). This study's results suggest that 18 F-NaF positron-emission tomography can be a useful noninvasive diagnostic tool to identify and localize plaque with high-risk characteristics. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02388412. © 2017 American Heart Association, Inc.

  3. What's New in the Medicine Cabinet?: A Panoramic Review of Clinically Relevant Information for the Busy Dermatologist.

    Science.gov (United States)

    Del Rosso, James Q; Zeichner, Joshua

    2014-01-01

    This article is the first in a periodic series of therapeutic topics with short reviews gleaned from major dermatology meetings, especially Scientific Poster Sessions, and is designed to provide information that may assist the readers in adapting information from the literature to their clinical practice. The topics covered in this issue are discussions of the clinical relevance of newer information about acne pathophysiology, acne in adult women, and topical corticosteroid spray formulations for chronic plaque psoriasis.

  4. Pregnancy outcomes in Ghana : Relavance of clinical decision making support tools for frontline providers of care

    NARCIS (Netherlands)

    Amoakoh-Coleman, M.

    2016-01-01

    Ghana’s slow progress towards attaining millennium development goal 5 has been associated with gaps in quality of care, particularly quality of clinical decision making for clients. This thesis reviews the relevance and effect of clinical decision making support tools on pregnancy

  5. Achieving graphical excellence: suggestions and methods for creating high-quality visual displays of experimental data.

    Science.gov (United States)

    Schriger, D L; Cooper, R J

    2001-01-01

    Graphics are an important means of communicating experimental data and results. There is evidence, however, that many of the graphics printed in scientific journals contain errors, redundancies, and lack clarity. Perhaps more important, many graphics fail to portray data at an appropriate level of detail, presenting summary statistics rather than underlying distributions. We seek to aid investigators in the production of high-quality graphics that do their investigations justice by providing the reader with optimum access to the relevant aspects of the data. The depiction of by-subject data, the signification of pairing when present, and the use of symbolic dimensionality (graphing different symbols to identify relevant subgroups) and small multiples (the presentation of an array of similar graphics each depicting one group of subjects) to portray stratification are stressed. Step-by-step instructions for the construction of high-quality graphics are offered. We hope that authors will incorporate these suggestions when developing graphics to accompany their manuscripts and that this process will lead to improvements in the graphical literacy of scientific journals. We also hope that journal editors will keep these principles in mind when refereeing manuscripts submitted for peer review.

  6. Nicotine at clinically relevant concentrations affects atrial inward rectifier potassium current sensitive to acetylcholine.

    Science.gov (United States)

    Bébarová, Markéta; Matejovič, Peter; Švecová, Olga; Kula, Roman; Šimurdová, Milena; Šimurda, Jiří

    2017-05-01

    Nicotine abuse is associated with variety of diseases including arrhythmias, most often atrial fibrillation (AF). Altered inward rectifier potassium currents including acetylcholine-sensitive current I K(Ach) are known to be related to AF pathogenesis. Since relevant data are missing, we aimed to investigate I K(Ach) changes at clinically relevant concentrations of nicotine. Experiments were performed by the whole cell patch clamp technique at 23 ± 1 °C on isolated rat atrial myocytes. Nicotine was applied at following concentrations: 4, 40 and 400 nM; ethanol at 20 mM (∼0.09%). Nicotine at 40 and 400 nM significantly activated constitutively active component of I K(Ach) with the maximum effect at 40 nM (an increase by ∼100%); similar effect was observed at -110 and -50 mV. Changes at 4 nM nicotine were negligible on average. Coapplication of 40 nM nicotine and 20 mM ethanol (which is also known to activate this current) did not show cumulative effect. In the case of acetylcholine-induced component of I K(Ach) , a dual effect of nicotine and its correlation with the current magnitude in control were apparent: the current was increased by nicotine in the cells showing small current in control and vice versa. The effect of 40 and 400 nM nicotine on acetylcholine-induced component of I K(Ach) was significantly different at -110 and -50 mV. We conclude that nicotine at clinically relevant concentrations significantly increased constitutively active component of I K(Ach) and showed a dual effect on its acetylcholine-induced component, similarly as ethanol. Synchronous application of nicotine and ethanol did not cause additive effect.

  7. Evaluation of Criteria-Based Clinical Audit in Improving Quality of ...

    African Journals Online (AJOL)

    Erah

    ABSTRACT. Study evaluated criteria–based clinical audit in measuring and improving quality of obstetric care for five life-threatening obstetric complications: obstetric haemorrhage, eclampsia, genital tract infections, obstructed labor and uterine rupture. Clinical management of 65 patients was audited using a 'before.

  8. Outcome measures in European patients with haemophilia: Survey of implementation in routine clinical practice, perception of relevance and recommendations by European treaters in the EHTSB.

    Science.gov (United States)

    Hermans, C; Klamroth, R; Richards, M; de Moerloose, P; Garrido, R P

    2017-03-01

    This study was conducted to evaluate the current implementation of outcome measures in routine clinical haemophilia practice and to explore and appreciate the perception of the relevance of such measures by treaters. A survey was completed by 19 of the 26 physicians involved in the European Haemophilia Therapy Strategy Board (EHTSB). Employing an extensive inventory of outcome measures used in patients with haemophilia, information was collected about the frequency of data collection and the subjective appreciation of their importance during clinic review. The survey revealed that most treaters currently collect data that are mainly related to the haemostatic treatment (consumption of concentrates) and the bleeding symptoms (number and location of bleeds) in a non-uniform and non-standardized way. By contrast, functional, physical and quality of life scorings are rarely used and show considerable heterogeneity between treaters. Also, many disparities emerged between practice and perception, in particular quality of life data that are perceived as being important but for most of the time are not collected. This survey represents, in our view, the first attempt to evaluate the actual utilization of outcome measures in haemophilia care. While the value of outcome measures is appreciated, they are not assessed regularly. Therefore, there is a need to include appropriate performance indicators (outcome measures) of haemophilia care in routine clinical practice. Consensus recommendations to provide a framework for achieving this aim are provided. © 2016 John Wiley & Sons Ltd.

  9. The Clinical, Symptom, and Quality-of-Life Characterization of a Well-Defined Group of Patients with Posttreatment Lyme Disease Syndrome.

    Science.gov (United States)

    Rebman, Alison W; Bechtold, Kathleen T; Yang, Ting; Mihm, Erica A; Soloski, Mark J; Novak, Cheryl B; Aucott, John N

    2017-01-01

    The increased incidence and geographic expansion of Lyme disease has made it the most common vector-borne infection in North America. Posttreatment Lyme disease syndrome (PTLDS) represents a subset of patients who remain ill following standard antibiotic therapy for Lyme disease. The spectrum of symptoms and their impact on quality of life remain largely unexplored among patients with well-documented PTLDS. To characterize a case series of patients with well-documented PTLDS compared to a sample of healthy controls. Sixty-one participants met the proposed case definition for PTLDS. Twenty-six healthy controls had neither a clinical history of Lyme disease nor current antibodies to Borrelia burgdorferi . Participants with PTLDS and controls were evaluated by physical exam, clinical laboratory testing, standardized questionnaires, and a 36-item current symptom list. Compared to controls, participants with PTLDS reported significantly greater fatigue, pain, sleep disturbance, and depression (Fatigue Severity Scale: 50.0 ± 10.6 vs. 19.8 ± 8.6; Short-Form McGill Pain Questionnaire: 13.7 ± 8.3 vs. 0.8 ± 1.9; Pittsburgh Sleep Quality Index: 10.1 ± 4.7 vs. 4.1 ± 2.1; Beck Depression Inventory-II: 15.1 ± 7.7 vs. 2.2 ± 3.2; p  < 0.001 for each), and significantly lower quality of life (SF-36 Physical Component Score: 33.9 ± 9.7 vs. 55.1 ± 6.2; Mental Component Score: 42.9 ± 10.1 vs. 54.2 ± 5.4; p  < 0.001 for each). Nineteen non-PTLDS-defining symptoms were found to be significantly more severe among participants with PTLDS than controls, including sleep difficultly and visual complaints. Initial delayed or misdiagnosis was characterized in 59.0% of participants with PTLDS, and 32.2% had abnormal vibratory sense. Although physical exam and clinical laboratory tests showed few objective abnormalities, standardized symptom questionnaires revealed that patients with PTLDS are highly and clinically significantly

  10. [Quality measurement using administrative data in mandatory quality assurance].

    Science.gov (United States)

    Heller, Günther; Szecsenyi, Joachim; Willms, Gerald; Broge, Björn

    2014-01-01

    For several years, the use of administrative data in mandatory quality measurement has been requested by several stakeholders in Germany. Main advantages of using administrative data include the reduction of documentary expenditures and the possibility to perform longitudinal quality analyses across different healthcare units. After a short introduction, a brief overview of the current use of administrative data for mandatory quality assurance as well as current developments is given, which will then be further exemplified by decubital ulcer prophylaxis. By using administrative data coding expenditures in this clinical area could be reduced by nine million data fields. At the same time the population analysed was expanded resulting in a more than tenfold increase in potentially quality-relevant events. Finally, perspectives, further developments, possibilities as well as limits of quality measurement with administrative data are discussed. Copyright © 2014. Published by Elsevier GmbH.

  11. Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

    Directory of Open Access Journals (Sweden)

    Vinko Peric

    2014-06-01

    Full Text Available In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.

  12. Stakeholder-Driven Quality Improvement: A Compelling Force for Clinical Practice Guidelines.

    Science.gov (United States)

    Rosenfeld, Richard M; Wyer, Peter C

    2018-01-01

    Clinical practice guideline development should be driven by rigorous methodology, but what is less clear is where quality improvement enters the process: should it be a priority-guiding force, or should it enter only after recommendations are formulated? We argue for a stakeholder-driven approach to guideline development, with an overriding goal of quality improvement based on stakeholder perceptions of needs, uncertainties, and knowledge gaps. In contrast, the widely used topic-driven approach, which often makes recommendations based only on randomized controlled trials, is driven by epidemiologic purity and evidence rigor, with quality improvement a downstream consideration. The advantages of a stakeholder-driven versus a topic-driven approach are highlighted by comparisons of guidelines for otitis media with effusion, thyroid nodules, sepsis, and acute bacterial rhinosinusitis. These comparisons show that stakeholder-driven guidelines are more likely to address the quality improvement needs and pressing concerns of clinicians and patients, including understudied populations and patients with multiple chronic conditions. Conversely, a topic-driven approach often addresses "typical" patients, based on research that may not reflect the needs of high-risk groups excluded from studies because of ethical issues or a desire for purity of research design.

  13. Anxiety and Quality of Life: Clinically Anxious Children with and without Autism Spectrum Disorders Compared

    Science.gov (United States)

    van Steensel, Francisca J. A.; Bogels, Susan M.; Dirksen, Carmen D.

    2012-01-01

    Comorbid anxiety disorders are common in children with autism spectrum disorders (ASD). However, studies comparing children with ASD to clinically anxious children are rare. This study investigated anxiety problems and health-related quality of life in children with high-functioning ASD and comorbid anxiety disorders (referred to as the ASD…

  14. [Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

    Science.gov (United States)

    Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

    2010-02-01

    To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

  15. Groundwater science relevant to the Great Lakes Water Quality Agreement: A status report

    Science.gov (United States)

    Grannemann, Norman G.; Van Stempvoort, Dale

    2016-01-01

    When the Great Lakes Water Quality Agreement (GLWQA) was signed in 1972 by the Governments of Canada and the United States (the “Parties”) (Environment Canada, 2013a), groundwater was not recognized as important to the water quality of the Lakes. At that time, groundwater and surface water were still considered as two separate systems, with almost no appreciation for their interaction. When the GLWQA was revised in 1978 (US Environmental Protection Agency (USEPA), 2012), groundwater contamination, such as that reported at legacy industrial sites such as those at Love Canal near the Niagara River, was squarely in the news. Consequently, the potential impacts of contaminated groundwater from such sites on Great Lakes water quality became a concern (Beck, 1979), and Annex 16 was added to the agreement, to address “pollution from contaminated groundwater” (Francis, 1989). However, no formal process for reporting under this annex was provided. The GLWQA Protocol in 1987 modified Annex 16 and called for progress reports beginning in 1988 (USEPA, 1988). The Protocol in 2012 provided a new Annex 8 to address groundwater more holistically (Environment 2 Canada, 2013b). Annex 8 (Environment Canada, 2013b) commits the Parties to coordinate groundwater science and management actions; as a first step, to “publish a report on the relevant and available groundwater science” by February 2015 (this report); and to “identify priorities for science activities and actions for groundwater management, protection, and remediation…” The broader mandate of Annex 8 is to (1) “identify groundwater impacts on the chemical, physical and biological integrity of the Waters of the Great Lakes;” (2) “analyze contaminants, including nutrients in groundwater, derived from both point and non-point sources impacting the Waters of the Great Lakes;” (3) “assess information gaps and science needs related to groundwater to protect the quality of the Waters of the Great Lakes

  16. Prevention of ventilator-associated pneumonia in the intensive care unit: A review of the clinically relevant recent advancements

    Directory of Open Access Journals (Sweden)

    Holly Keyt

    2014-01-01

    Full Text Available Ventilator-associated pneumonia (VAP is one of the most commonly encountered hospital-acquired infections in intensive care units and is associated with significant morbidity and high costs of care. The pathophysiology, epidemiology, treatment and prevention of VAP have been extensively studied for decades, but a clear prevention strategy has not yet emerged. In this article we will review recent literature pertaining to evidence-based VAP-prevention strategies that have resulted in clinically relevant outcomes. A multidisciplinary strategy for prevention of VAP is recommended. Those interventions that have been shown to have a clinical impact include the following: (i Non-invasive positive pressure ventilation for able patients, especially in immunocompromised patients, with acute exacerbation of chronic obstructive pulmonary disease or pulmonary oedema, (ii Sedation and weaning protocols for those patients who do require mechanical ventilation, (iii Mechanical ventilation protocols including head of bed elevation above 30 degrees and oral care, and (iv Removal of subglottic secretions. Other interventions, such as selective digestive tract decontamination, selective oropharyngeal decontamination and antimicrobial-coated endotracheal tubes, have been tested in different studies. However, the evidence for the efficacy of these measures to reduce VAP rates is not strong enough to recommend their use in clinical practice. In numerous studies, the implementation of VAP prevention bundles to clinical practice was associated with a significant reduction in VAP rates. Future research that considers clinical outcomes as primary endpoints will hopefully result in more detailed prevention strategies.

  17. Evaluation of Acne Quality of Life and Clinical Severity in Acne Female Adults

    Directory of Open Access Journals (Sweden)

    Amal Kokandi

    2010-01-01

    Full Text Available Acne is a common disease especially among teenagers. It has a considerable psychological impact on affected individuals. The aim of this paper was to assess if the effect of acne on acne-related quality of life is correlated to acne clinical severity. 112 university female students attending the university medical clinics with acne complaints were examined. Cardiff Acne Disability Index (CADI was used to assess acne-related quality of life, and global acne grading system (GAGS was used to assess clinical severity of acne. There was no correlation between acne severity (GAGS scoring system and quality of life impairment as assessed by CADI score (=0.145, =.127. Additionally, CADI score did not correlate with disease duration or age of patients. We therefore conclude that acne clinical severity alone does not affect acne-related quality of life changes. Many other factors might play a role.

  18. High-resolution typing of Chlamydia trachomatis: epidemiological and clinical uses.

    Science.gov (United States)

    de Vries, Henry J C; Schim van der Loeff, Maarten F; Bruisten, Sylvia M

    2015-02-01

    A state-of-the-art overview of molecular Chlamydia trachomatis typing methods that are used for routine diagnostics and scientific studies. Molecular epidemiology uses high-resolution typing techniques such as multilocus sequence typing, multilocus variable number of tandem repeats analysis, and whole-genome sequencing to identify strains based on their DNA sequence. These data can be used for cluster, network and phylogenetic analyses, and are used to unveil transmission networks, risk groups, and evolutionary pathways. High-resolution typing of C. trachomatis strains is applied to monitor treatment efficacy and re-infections, and to study the recent emergence of lymphogranuloma venereum (LGV) amongst men who have sex with men in high-income countries. Chlamydia strain typing has clinical relevance in disease management, as LGV needs longer treatment than non-LGV C. trachomatis. It has also led to the discovery of a new variant Chlamydia strain in Sweden, which was not detected by some commercial C. trachomatis diagnostic platforms. After a brief history and comparison of the various Chlamydia typing methods, the applications of the current techniques are described and future endeavors to extend scientific understanding are formulated. High-resolution typing will likely help to further unravel the pathophysiological mechanisms behind the wide clinical spectrum of chlamydial disease.

  19. Feasibility of peer assessment and clinical audit to self-regulate the quality of physiotherapy services: a mixed methods study.

    Science.gov (United States)

    Maas, Marjo J M; Nijhuis-van der Sanden, Maria W G; Driehuis, Femke; Heerkens, Yvonne F; van der Vleuten, Cees P M; van der Wees, Philip J

    2017-02-10

    To evaluate the feasibility of a quality improvement programme aimed to enhance the client-centeredness, effectiveness and transparency of physiotherapy services by addressing three feasibility domains: (1) acceptability of the programme design, (2) appropriateness of the implementation strategy and (3) impact on quality improvement. Mixed methods study. 64 physiotherapists working in primary care, organised in a network of communities of practice in the Netherlands. The programme contained: (1) two cycles of online self-assessment and peer assessment (PA) of clinical performance using client records and video-recordings of client communication followed by face-to-face group discussions, and (2) clinical audit assessing organisational performance. Assessment was based on predefined performance indicators which could be scored on a 5-point Likert scale. Discussions addressed performance standards and scoring differences. All feasibility domains were evaluated qualitatively with two focus groups and 10 in-depth interviews. In addition, we evaluated the impact on quality improvement quantitatively by comparing self-assessment and PA scores in cycles 1 and 2. We identified critical success features relevant to programme development and implementation, such as clarifying expectations at baseline, training in PA skills, prolonged engagement with video-assessment and competent group coaches. Self-reported impact on quality improvement included awareness of clinical and organisational performance, improved evidence-based practice and client-centeredness and increased motivation to self-direct quality improvement. Differences between self-scores and peer scores on performance indicators were not significant. Between cycles 1 and 2, scores for record keeping showed significant improvement, however not for client communication. This study demonstrated that bottom-up initiatives to improve healthcare quality can be effective. The results justify ongoing evaluation to inform

  20. Macrotrabecular-massive hepatocellular carcinoma: A distinctive histological subtype with clinical relevance.

    Science.gov (United States)

    Ziol, Marianne; Poté, Nicolas; Amaddeo, Giuliana; Laurent, Alexis; Nault, Jean-Charles; Oberti, Frédéric; Costentin, Charlotte; Michalak, Sophie; Bouattour, Mohamed; Francoz, Claire; Pageaux, Georges Philippe; Ramos, Jeanne; Decaens, Thomas; Luciani, Alain; Guiu, Boris; Vilgrain, Valérie; Aubé, Christophe; Derman, Jonathan; Charpy, Cécile; Zucman-Rossi, Jessica; Barget, Nathalie; Seror, Olivier; Ganne-Carrié, Nathalie; Paradis, Valérie; Calderaro, Julien

    2017-12-27

    We recently identified a novel histological subtype of hepatocellular carcinoma, designated as "macrotrabecular-massive" (MTM-HCC) and associated with specific molecular features. In order to assess the clinical relevance of this novel variant, we aimed to investigate its prognostic value in two large series of patients with HCC treated either by surgical resection or radiofrequency ablation (RFA). We retrospectively included 237 HCC surgical samples and 284 HCC liver biopsies from patients treated by surgical resection and RFA, respectively. Histological slides were reviewed by pathologists specialized in liver disease, and the MTM-HCC subtype was defined by the presence of a predominant (>50%) macrotrabecular architecture (more than 6 cells thick). The main clinical and biological features were recorded at baseline. Clinical endpoints were early and overall recurrence. The MTM-HCC subtype was identified in 12% of the whole cohort (16% of surgically resected samples, 8.5% of liver biopsy samples). It was associated at baseline with known poor prognostic factors (tumor size, AFP level, satellite nodules and vascular invasion). Multivariate analysis showed that MTM-HCC subtype was an independent predictor of early and overall recurrence (surgical series: OR 3.03 (1.38-6.65), p=0.006 and 2.76 (1.63-4.67), pvalue was retained even after patients stratification according to common clinical, biological and pathological features of aggressiveness. No other baseline parameter was independently associated to recurrence in the RFA series. The MTM-HCC subtype, reliably observed in 12% of patients eligible for a curative treatment, represents an aggressive form of HCC that may require more specific therapeutic strategies. This article is protected by copyright. All rights reserved. © 2017 by the American Association for the Study of Liver Diseases.

  1. Sarcopenia: origins and clinical relevance

    Science.gov (United States)

    To a considerable extent, the advent of the term sarcopenia has contributed to the focus on this important condition and its effects on the quality of life and care of older persons. It is hoped that the advances in our understanding of the etiology and treatment of sarcopenia will further contribut...

  2. Perceived Service Quality models: Are They Still Relevant?

    OpenAIRE

    Polyakova, Olga; Mirza, Mohammed T.

    2015-01-01

    This paper reviews the concept of perceived service quality and provides an update to the body of service quality knowledge. It consolidates the pathway of perceived service quality concept, from its emergence to the research model’s development. It also critically reviews service characteristics as prerequisites of perceived service quality conceptualisation. The examination of six perceived service quality models is intended to identify a superior model that could be used by further researc...

  3. Implementation of quality management for clinical bacteriology in low-resource settings.

    Science.gov (United States)

    Barbé, B; Yansouni, C P; Affolabi, D; Jacobs, J

    2017-07-01

    The declining trend of malaria and the recent prioritization of containment of antimicrobial resistance have created a momentum to implement clinical bacteriology in low-resource settings. Successful implementation relies on guidance by a quality management system (QMS). Over the past decade international initiatives were launched towards implementation of QMS in HIV/AIDS, tuberculosis and malaria. To describe the progress towards accreditation of medical laboratories and to identify the challenges and best practices for implementation of QMS in clinical bacteriology in low-resource settings. Published literature, online reports and websites related to the implementation of laboratory QMS, accreditation of medical laboratories and initiatives for containment of antimicrobial resistance. Apart from the limitations of infrastructure, equipment, consumables and staff, QMS are challenged with the complexity of clinical bacteriology and the healthcare context in low-resource settings (small-scale laboratories, attitudes and perception of staff, absence of laboratory information systems). Likewise, most international initiatives addressing laboratory health strengthening have focused on public health and outbreak management rather than on hospital based patient care. Best practices to implement quality-assured clinical bacteriology in low-resource settings include alignment with national regulations and public health reference laboratories, participating in external quality assurance programmes, support from the hospital's management, starting with attainable projects, conducting error review and daily bench-side supervision, looking for locally adapted solutions, stimulating ownership and extending existing training programmes to clinical bacteriology. The implementation of QMS in clinical bacteriology in hospital settings will ultimately boost a culture of quality to all sectors of healthcare in low-resource settings. Copyright © 2017 The Authors. Published by

  4. Quality of Life Outcomes after Primary Treatment for Clinically Localised Prostate Cancer: A Systematic Review.

    Science.gov (United States)

    Lardas, Michael; Liew, Matthew; van den Bergh, Roderick C; De Santis, Maria; Bellmunt, Joaquim; Van den Broeck, Thomas; Cornford, Philip; Cumberbatch, Marcus G; Fossati, Nicola; Gross, Tobias; Henry, Ann M; Bolla, Michel; Briers, Erik; Joniau, Steven; Lam, Thomas B; Mason, Malcolm D; Mottet, Nicolas; van der Poel, Henk G; Rouvière, Olivier; Schoots, Ivo G; Wiegel, Thomas; Willemse, Peter-Paul M; Yuan, Cathy Yuhong; Bourke, Liam

    2017-12-01

    Current evidence-based management for clinically localised prostate cancer includes active surveillance, surgery, external beam radiotherapy (EBRT) and brachytherapy. The impact of these treatment modalities on quality of life (QoL) is uncertain. To systematically review comparative studies investigating disease-specific QoL outcomes as assessed by validated cancer-specific patient-reported outcome measures with at least 1 yr of follow-up after primary treatment for clinically localised prostate cancer. MEDLINE, EMBASE, AMED, PsycINFO, and Cochrane Library were searched to identify relevant studies. Studies were critically appraised for the risk of bias. A narrative synthesis was undertaken. Of 11486 articles identified, 18 studies were eligible for inclusion, including three randomised controlled trials (RCTs; follow-up range: 60-72 mo) and 15 nonrandomised comparative studies (follow-up range: 12-180 mo) recruiting a total of 13604 patients. Two RCTs recruited small cohorts and only one was judged to have a low risk of bias. The quality of evidence from observational studies was low to moderate. For a follow-up of up to 6 yr, active surveillance was found to have the lowest impact on cancer-specific QoL, surgery had a negative impact on urinary and sexual function when compared with active surveillance and EBRT, and EBRT had a negative impact on bowel function when compared with active surveillance and surgery. Data from one small RCT reported that brachytherapy has a negative impact on urinary function 1 yr post-treatment, but no significant urinary toxicity was reported at 5 yr. This is the first systematic review comparing the impact of different primary treatments on cancer-specific QoL for men with clinically localised prostate cancer, using validated cancer-specific patient-reported outcome measures only. There is robust evidence that choice of primary treatment for localised prostate cancer has distinct impacts on patients' QoL. This should be discussed in

  5. Continuous quality improvement for the clinical decision unit.

    Science.gov (United States)

    Mace, Sharon E

    2004-01-01

    Clinical decision units (CDUs) are a relatively new and growing area of medicine in which patients undergo rapid evaluation and treatment. Continuous quality improvement (CQI) is important for the establishment and functioning of CDUs. CQI in CDUs has many advantages: better CDU functioning, fulfillment of Joint Commission on Accreditation of Healthcare Organizations mandates, greater efficiency/productivity, increased job satisfaction, better performance improvement, data availability, and benchmarking. Key elements include a database with volume indicators, operational policies, clinical practice protocols (diagnosis specific/condition specific), monitors, benchmarks, and clinical pathways. Examples of these important parameters are given. The CQI process should be individualized for each CDU and hospital.

  6. Achieving organisational competence for clinical leadership: the role of high performance work systems.

    Science.gov (United States)

    Leggat, Sandra G; Balding, Cathy

    2013-01-01

    While there has been substantial discussion about the potential for clinical leadership in improving quality and safety in healthcare, there has been little robust study. The purpose of this paper is to present the results of a qualitative study with clinicians and clinician managers to gather opinions on the appropriate content of an educational initiative being planned to improve clinical leadership in quality and safety among medical, nursing and allied health professionals working in primary, community and secondary care. In total, 28 clinicians and clinician managers throughout the state of Victoria, Australia, participated in focus groups to provide advice on the development of a clinical leadership program in quality and safety. An inductive, thematic analysis was completed to enable the themes to emerge from the data. Overwhelmingly the participants conceptualised clinical leadership in relation to organisational factors. Only four individual factors, comprising emotional intelligence, resilience, self-awareness and understanding of other clinical disciplines, were identified as being important for clinical leaders. Conversely seven organisational factors, comprising role clarity and accountability, security and sustainability for clinical leaders, selective recruitment into clinical leadership positions, teamwork and decentralised decision making, training, information sharing, and transformational leadership, were seen as essential, but the participants indicated they were rarely addressed. The human resource management literature includes these seven components, with contingent reward, reduced status distinctions and measurement of management practices, as the essential organisational underpinnings of high performance work systems. The results of this study propose that clinical leadership is an organisational property, suggesting that capability frameworks and educational programs for clinical leadership need a broader organisation focus. The paper

  7. Use of plan quality degradation to evaluate tradeoffs in delivery efficiency and clinical plan metrics arising from IMRT optimizer and sequencer compromises

    Science.gov (United States)

    Wilkie, Joel R.; Matuszak, Martha M.; Feng, Mary; Moran, Jean M.; Fraass, Benedick A.

    2013-01-01

    Purpose: Plan degradation resulting from compromises made to enhance delivery efficiency is an important consideration for intensity modulated radiation therapy (IMRT) treatment plans. IMRT optimization and/or multileaf collimator (MLC) sequencing schemes can be modified to generate more efficient treatment delivery, but the effect those modifications have on plan quality is often difficult to quantify. In this work, the authors present a method for quantitative assessment of overall plan quality degradation due to tradeoffs between delivery efficiency and treatment plan quality, illustrated using comparisons between plans developed allowing different numbers of intensity levels in IMRT optimization and/or MLC sequencing for static segmental MLC IMRT plans. Methods: A plan quality degradation method to evaluate delivery efficiency and plan quality tradeoffs was developed and used to assess planning for 14 prostate and 12 head and neck patients treated with static IMRT. Plan quality was evaluated using a physician's predetermined “quality degradation” factors for relevant clinical plan metrics associated with the plan optimization strategy. Delivery efficiency and plan quality were assessed for a range of optimization and sequencing limitations. The “optimal” (baseline) plan for each case was derived using a clinical cost function with an unlimited number of intensity levels. These plans were sequenced with a clinical MLC leaf sequencer which uses >100 segments, assuring delivered intensities to be within 1% of the optimized intensity pattern. Each patient's optimal plan was also sequenced limiting the number of intensity levels (20, 10, and 5), and then separately optimized with these same numbers of intensity levels. Delivery time was measured for all plans, and direct evaluation of the tradeoffs between delivery time and plan degradation was performed. Results: When considering tradeoffs, the optimal number of intensity levels depends on the treatment

  8. Tomographic diagnosis and relevant aspects of otosclerosis

    International Nuclear Information System (INIS)

    Gaiotti, Juliana Oggioni; Gomes, Natalia Delage; Costa, Ana Maria Doffemond; Villela, Caroline Laurita Batista Couto; Moreira, Wanderval; Diniz, Renata Lopes Furletti Caldeira

    2013-01-01

    A literature review and pictorial essay were developed to discuss the importance of knowing the main findings and locations of otosclerosis at multidetector computed tomography (MDCT). The authors performed a retrospective review of cases of otosclerosis diagnosed in their institution by means of high resolution multidetector computed tomography. Otosclerosis corresponds to otic capsule dysplasia characterized by metabolic derangement of its endochondral layer. Such condition constitutes a relevant cause of sensorineural hearing loss, affecting about 7% to 10% of the general population. The diagnosis is usually clinical, but imaging methods play a significant role in the anatomical detailing, differential diagnosis, surgical planning and evaluation of postoperative complications. Among such methods, the relevance of MDCT is highlighted. Radiologists should be familiar with the MDCT findings of otosclerosis, as well as with the temporal bone anatomy to assist in the appropriate clinical management of this disease. (author)

  9. Tomographic diagnosis and relevant aspects of otosclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Gaiotti, Juliana Oggioni; Gomes, Natalia Delage; Costa, Ana Maria Doffemond; Villela, Caroline Laurita Batista Couto; Moreira, Wanderval; Diniz, Renata Lopes Furletti Caldeira, E-mail: jugaiotti@gmail.com [Hospital Mater Dei-Mater Imagem, Belo Horizonte, MG (Brazil)

    2013-09-15

    A literature review and pictorial essay were developed to discuss the importance of knowing the main findings and locations of otosclerosis at multidetector computed tomography (MDCT). The authors performed a retrospective review of cases of otosclerosis diagnosed in their institution by means of high resolution multidetector computed tomography. Otosclerosis corresponds to otic capsule dysplasia characterized by metabolic derangement of its endochondral layer. Such condition constitutes a relevant cause of sensorineural hearing loss, affecting about 7% to 10% of the general population. The diagnosis is usually clinical, but imaging methods play a significant role in the anatomical detailing, differential diagnosis, surgical planning and evaluation of postoperative complications. Among such methods, the relevance of MDCT is highlighted. Radiologists should be familiar with the MDCT findings of otosclerosis, as well as with the temporal bone anatomy to assist in the appropriate clinical management of this disease. (author)

  10. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  11. Understanding Magnetic Resonance Imaging of Knee Cartilage Repair: A Focus on Clinical Relevance.

    Science.gov (United States)

    Hayashi, Daichi; Li, Xinning; Murakami, Akira M; Roemer, Frank W; Trattnig, Siegfried; Guermazi, Ali

    2017-06-01

    The aims of this review article are (a) to describe the principles of morphologic and compositional magnetic resonance imaging (MRI) techniques relevant for the imaging of knee cartilage repair surgery and their application to longitudinal studies and (b) to illustrate the clinical relevance of pre- and postsurgical MRI with correlation to intraoperative images. First, MRI sequences that can be applied for imaging of cartilage repair tissue in the knee are described, focusing on comparison of 2D and 3D fast spin echo and gradient recalled echo sequences. Imaging features of cartilage repair tissue are then discussed, including conventional (morphologic) MRI and compositional MRI techniques. More specifically, imaging techniques for specific cartilage repair surgery techniques as described above, as well as MRI-based semiquantitative scoring systems for the knee cartilage repair tissue-MR Observation of Cartilage Repair Tissue and Cartilage Repair OA Knee Score-are explained. Then, currently available surgical techniques are reviewed, including marrow stimulation, osteochondral autograft, osteochondral allograft, particulate cartilage allograft, autologous chondrocyte implantation, and others. Finally, ongoing research efforts and future direction of cartilage repair tissue imaging are discussed.

  12. Opportunities for Cancer-relevant Innovative Technologies with Transformative Potential | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    The National Cancer Institute (NCI) is seeking input from the community on identifying priorities with regards to supporting innovative technology development for cancer-relevant research. While the NCI provides support for technology development through a variety of mechanisms, it is important to understand whether or not these are sufficient for catalyzing and supporting the development of tools with significant potential for advancing important fields of cancer research or clinical care.

  13. Perspectives on creating clinically relevant blast models for mild traumatic brain injury and post traumatic stress disorder symptoms

    Directory of Open Access Journals (Sweden)

    Lisa eBrenner

    2012-03-01

    Full Text Available Military personnel are returning from Iraq and Afghanistan and reporting non-specific physical (somatic, behavioral, psychological, and cognitive symptoms. Many of these symptoms are frequently associated with mild traumatic brain injury (mTBI and/or post traumatic stress disorder (PTSD. Despite significant attention and advances in assessment and intervention for these two conditions, challenges persist. To address this, clinically relevant blast models are essential in the full characterization of this type of injury, as well as in the testing and identification of potential treatment strategies. In this publication, existing diagnostic challenges and current treatment practices for mTBI and/or PTSD will be summarized, along with suggestions regarding how what has been learned from existing models of PTSD and traditional mechanism (e.g., non-blast TBI can be used to facilitate the development of clinically relevant blast models.

  14. Tumor microenvironment in head and neck squamous cell carcinomas: predictive value and clinical relevance of hypoxic markers. A review.

    Science.gov (United States)

    Hoogsteen, Ilse J; Marres, Henri A M; Bussink, Johan; van der Kogel, Albert J; Kaanders, Johannes H A M

    2007-06-01

    Hypoxia and tumor cell proliferation are important factors determining the treatment response of squamous cell carcinomas of the head and neck. Successful approaches have been developed to counteract these resistance mechanisms although usually at the cost of increased short- and long-term side effects. To provide the best attainable quality of life for individual patients and the head and neck cancer patient population as a whole, it is of increasing importance that tools be developed that allow a better selection of patients for these intensified treatments. A literature review was performed with special focus on the predictive value and clinical relevance of endogenous hypoxia-related markers. New methods for qualitative and quantitative assessment of functional microenvironmental parameters such as hypoxia, proliferation, and vasculature have identified several candidate markers for future use in predictive assays. Hypoxia-related markers include hypoxia inducible factor (HIF)-1alpha, carbonic anhydrase IX, glucose transporters, erythropoietin receptor, osteopontin, and others. Although several of these markers and combinations of markers are associated with treatment outcome, their clinical value as predictive factors remains to be established. A number of markers and marker profiles have emerged that may have potential as a predictive assay. Validation of these candidate assays requires testing in prospective trials comparing standard treatment against experimental treatments targeting the related microregional constituent. (c) 2007 Wiley Periodicals, Inc. Head Neck, 2007.

  15. [Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

    Science.gov (United States)

    Xing, D; Wang, B; Lin, J H

    2017-06-01

    At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

  16. Clinical empathy and narrative competence: the relevance of reading talmudic legends as literary fiction.

    Science.gov (United States)

    Davidson, John H

    2015-04-01

    The "curative potential" in almost any clinical setting depends on a caregiver establishing and maintaining an empathic connection with patients so as to achieve "narrative competence" in discerning and acting in accord with their preferences and best interests. The "narrative medicine" model of shared "close reading of literature and reflective writing" among clinicians as a means of fostering a capacity for clinical empathy has gained validation with recent empirical studies demonstrating the enhancement of theory of mind (ToM), broadly conceived as empathy, in readers of literary fiction. Talmudic legends, like that of Rabbi Judah's death, are under-appreciated, relevant sources of literary fiction for these efforts. The limitations of narrative medicine are readily counterbalanced by simultaneously practiced attention to traditional bioethical principles, including-especially-beneficence, non-maleficence, and autonomy.

  17. Quality of reporting of descriptive studies in implant dentistry. Critical aspects in design, outcome assessment and clinical relevance

    NARCIS (Netherlands)

    Meijer, Henny J. A.; Raghoebar, Gerry M.

    Objectives: The aim of this study was to conduct a review on quality of reporting on descriptive studies in implant dentistry using the STROBE Statement and to analyse possible changes in quality of reporting on descriptive studies in implant dentistry over time. Material and Methods: A hand search

  18. Evaluation of clinical teaching quality in competency-based residency training in Lithuania.

    Science.gov (United States)

    Vaižgėlienė, Eglė; Padaiga, Žilvinas; Rastenytė, Daiva; Tamelis, Algimantas; Petrikonis, Kęstutis; Fluit, Cornelia

    2017-12-01

    In 2013, all residency programs at the Lithuanian University of Health Sciences were renewed into the competency-based medical education curriculum (CBME). In 2015, we implemented the validated EFFECT questionnaire together with the EFFECT-System for quality assessment of clinical teaching in residency training. The aim of this study was to investigate the influence of characteristics of the resident (year of training) and clinical teacher (gender, age, and type of academic position) on teaching quality, as well as to assess areas for teaching quality improvement. Residents from 7 different residency study programs filled out 333 EFFECT questionnaires evaluating 146 clinical teachers. We received 143 self-evaluations of clinical teachers using the same questionnaire. Items were scored on a 6-point Likert scale. Main outcome measures were residents' mean overall (MOS), mean subdomain (MSS) and clinical teachers' self-evaluation scores. The overall comparisons of MOS and MSS across study groups and subgroups were done using Student's t test and ANOVA for trend. The intraclass correlation coefficient (ICC) was calculated in order to see how residents' evaluations match with self-evaluations for every particular teacher. To indicate areas for quality improvement items were analyzed subtracting their mean score from the respective (sub)domain score. MOS for domains of "role modeling", "task allocation", "feedback", "teaching methodology" and "assessment" valued by residents were significantly higher than those valued by teachers (Pevaluation questionnaires were rated significantly higher by residents in role modeling subdomains (Phigher than the female teachers (Phigher (Pevaluations of clinical teachers are influenced by teachers' age, gender, year of residency training, type of teachers' academic position and whether or not a clinical teacher performed self-evaluation. Development of CBME should be focused on the continuous evaluation of quality, clinical teachers

  19. Bottom–up protein identifications from microliter quantities of individual human tear samples. Important steps towards clinical relevance.

    Directory of Open Access Journals (Sweden)

    Peter Raus

    2015-12-01

    With 375 confidently identified proteins in the healthy adult tear, the obtained results are comprehensive and in large agreement with previously published observations on pooled samples of multiple patients. We conclude that, to a limited extent, bottom–up tear protein identifications from individual patients may have clinical relevance.

  20. High engagement, high quality: A guiding framework for developing empirically informed asynchronous e-learning programs for health professional educators.

    Science.gov (United States)

    Sinclair, Peter M; Levett-Jones, Tracey; Morris, Amanda; Carter, Ben; Bennett, Paul N; Kable, Ashley

    2017-03-01

    E-learning involves the transfer of skills and knowledge via technology so that learners can access meaningful and authentic educational materials. While learner engagement is important, in the context of healthcare education, pedagogy must not be sacrificed for edu-tainment style instructional design. Consequently, health professional educators need to be competent in the use of current web-based educational technologies so that learners are able to access relevant and engaging e-learning materials without restriction. The increasing popularity of asynchronous e-learning programs developed for use outside of formal education institutions has made this need more relevant. In these contexts, educators must balance design and functionality to deliver relevant, cost-effective, sustainable, and accessible programs that overcome scheduling and geographic barriers for learners. This paper presents 10 guiding design principles and their application in the development of an e-learning program for general practice nurses focused on behavior change. Consideration of these principles will assist educators to develop high quality, pedagogically sound, engaging, and interactive e-learning resources. © 2017 John Wiley & Sons Australia, Ltd.

  1. TU-AB-207A-03: Image Quality, Dose, and Clinical Applications

    Energy Technology Data Exchange (ETDEWEB)

    Dong, F. [The Cleveland Clinic (United States)

    2016-06-15

    in the reconstructed images. Because of the limited scope of this course, only major imaging artifacts, their appearance, and possible mitigation and corrections will be discussed. Assessment of the performance of a CT scanner is a complicated subject. Procedures to measure common image quality metrics such as high contrast spatial resolution, low contrast detectability, and slice profile will be described. The reason why these metrics used for FBP may not be sufficient for statistical iterative reconstruction will be explained. Optimizing radiation dose requires comprehension of CT dose metrics. This course will briefly describe various dose metrics, and interaction with acquisition parameters and patient habitus. CT is among the most frequently used imaging tools due to its superior image quality, easy to operate, and a broad range of applications. This course will present several interesting CT applications such as a mobile CT unit on an ambulance for stroke patients, low dose lung cancer screening, and single heartbeat cardiac CT. Learning Objectives: Understand the function and impact of major components of X-ray tube on the image quality. Understand the function and impact of major components of CT detector on the image quality. Be familiar with the basic procedure of CT image reconstruction. Understand the effect of image reconstruction on CT image quality and artifacts. Understand the root causes of common CT image artifacts. Be familiar with image quality metrics especially high and low contrast resolution, noise power spectrum, slice sensitivity profile, etc. Understand why basic image quality metrics used for FBP may not be sufficient to characterize the performance of advanced iterative reconstruction. Be familiar with various CT dose metrics and their interaction with acquisition parameters. New development in advanced CT clinical applications. JH: Employee of GE Healthcare. FD: No disclosure.; J. Hsieh, Jiang Hsieh is an employee of GE Healthcare.

  2. TU-AB-207A-03: Image Quality, Dose, and Clinical Applications

    International Nuclear Information System (INIS)

    Dong, F.

    2016-01-01

    in the reconstructed images. Because of the limited scope of this course, only major imaging artifacts, their appearance, and possible mitigation and corrections will be discussed. Assessment of the performance of a CT scanner is a complicated subject. Procedures to measure common image quality metrics such as high contrast spatial resolution, low contrast detectability, and slice profile will be described. The reason why these metrics used for FBP may not be sufficient for statistical iterative reconstruction will be explained. Optimizing radiation dose requires comprehension of CT dose metrics. This course will briefly describe various dose metrics, and interaction with acquisition parameters and patient habitus. CT is among the most frequently used imaging tools due to its superior image quality, easy to operate, and a broad range of applications. This course will present several interesting CT applications such as a mobile CT unit on an ambulance for stroke patients, low dose lung cancer screening, and single heartbeat cardiac CT. Learning Objectives: Understand the function and impact of major components of X-ray tube on the image quality. Understand the function and impact of major components of CT detector on the image quality. Be familiar with the basic procedure of CT image reconstruction. Understand the effect of image reconstruction on CT image quality and artifacts. Understand the root causes of common CT image artifacts. Be familiar with image quality metrics especially high and low contrast resolution, noise power spectrum, slice sensitivity profile, etc. Understand why basic image quality metrics used for FBP may not be sufficient to characterize the performance of advanced iterative reconstruction. Be familiar with various CT dose metrics and their interaction with acquisition parameters. New development in advanced CT clinical applications. JH: Employee of GE Healthcare. FD: No disclosure.; J. Hsieh, Jiang Hsieh is an employee of GE Healthcare.

  3. Characteristics of Spanish articles of "scientific quality" cited in clinical practice guidelines on mental health.

    Science.gov (United States)

    Permanyer-Miralda, Gaietà; Adam, Paula; Guillamón, Imma; Solans-Domènech, Maite; Pons, Joan M V

    2013-01-01

    The study aims to illustrate the impact of Spanish research in clinical decision making. To this end, we analysed the characteristics of the most significant Spanish publications cited in clinical practice guidelines (CPG) on mental health. We conducted a descriptive qualitative study on the characteristics of ten articles cited in Spanish CPG on mental health, and selected for their "scientific quality". We analysed the content of the articles on the basis of the following characteristics: topics, study design, research centres, scientific and practical relevance, type of funding, and area or influence of the reference to the content of the guidelines. Among the noteworthy studies, some basic science studies, which have examined the establishment of genetic associations in the pathogenesis of mental illness are included, and others on the effectiveness of educational interventions. The content of those latter had more influence on the GPC, because they were cited in the summary of the scientific evidence or in the recommendations. Some of the outstanding features in the selected articles are the sophisticated designs (experimental or analytical), and the number of study centres, especially in international collaborations. Debate or refutation of previous findings on controversial issues may have also contributed to the extensive citation of work. The inclusion of studies in the CPG is not a sufficient condition of "quality", but their description can be instructive for the design of future research or publications. Copyright © 2012 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

  4. Quality, risk management and governance in mental health: an overview.

    Science.gov (United States)

    Callaly, Tom; Arya, Dinesh; Minas, Harry

    2005-03-01

    To consider the origin, current emphasis and relevance of the concepts of quality, risk management and clinical governance in mental health. Increasingly, health service boards and management teams are required to give attention to clinical governance rather than corporate governance alone. Clinical governance is a unifying quality concept that aims to produce a structure and systems to assure and improve the quality of clinical services by promoting an integrated and organization-wide approach towards continuous quality improvement. Many psychiatrists will find the reduction in clinical autonomy, the need to consider the welfare of the whole population as well as the individual patient for whom they are responsible, and the requirement that they play a part in a complex systems approach to quality improvement to be a challenge. Avoiding or ignoring this challenge will potentially lead to conflict with modern management approaches and increased loss of influence on future developments in mental health services.

  5. Why is the center of evidence - based dermatology relevant to Indian dermatology ?

    Directory of Open Access Journals (Sweden)

    Williams Hywel

    2009-01-01

    Full Text Available Evidence-based dermatology is the application of high-quality evidence to the care of individual patients with skin diseases. The Centre of Evidence-Based Dermatology in the UK promotes activities in this field through its three interlinking cogs, composed of the international Cochrane Skin Group, the UK Dermatology Clinical Trials Network (UKDCTN, and the UK national electronic library for skin disorders. The Cochrane Skin Group summarises what is already known about health care interventions by supporting systematic reviews of relevant randomized controlled trials (RCTs. The UKDCTN then addresses the key research gaps identified in systematic reviews by coordinating and carrying out well-designed RCTs. The Skin Disorders specialist library then plays a key role in disseminating new knowledge from systematic reviews and RCTs to a community of clinical users. The electronic resources at the Centre of Evidence-Based Dermatology are all freely available to Indian Dermatologists who can use the resources in a way that could benefit their patients. Such new knoweldge only has value if it is shared and used.

  6. The utility of ultra-high performance supercritical fluid chromatography-tandem mass spectrometry (UHPSFC-MS/MS) for clinically relevant steroid analysis.

    Science.gov (United States)

    Storbeck, Karl-Heinz; Gilligan, Lorna; Jenkinson, Carl; Baranowski, Elizabeth S; Quanson, Jonathan L; Arlt, Wiebke; Taylor, Angela E

    2018-05-15

    Liquid chromatography tandem mass spectrometry (LC-MS/MS) assays are considered the reference standard for serum steroid hormone analyses, while full urinary steroid profiles are only achievable by gas chromatography (GC-MS). Both LC-MS/MS and GC-MS have well documented strengths and limitations. Recently, commercial ultra-high performance supercritical fluid chromatography-tandem mass spectrometry (UHPSFC-MS/MS) systems have been developed. These systems combine the resolution of GC with the high-throughput capabilities of UHPLC. Uptake of this new technology into research and clinical labs has been slow, possibly due to the perceived increase in complexity. Here we therefore present fundamental principles of UHPSFC-MS/MS and the likely applications for this technology in the clinical research setting, while commenting on potential hurdles based on our experience to date. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  7. Breaking the mould without breaking the system: the development and pilot of a clinical dashboard at The Prince Charles Hospital.

    Science.gov (United States)

    Clark, Kevin W; Whiting, Elizabeth; Rowland, Jeffrey; Thompson, Leah E; Missenden, Ian; Schellein, Gerhard

    2013-06-01

    There is a vast array of clinical and quality data available within healthcare organisations. The availability of this data in a timely and easy to visualise way is an essential component of high-performing healthcare teams. It is recognised that good quality information is a driver of performance for clinical teams and helps ensure best possible care for patients. In 2012 the Internal Medicine Program at The Prince Charles Hospital developed a clinical dashboard that displays locally relevant information alongside relevant hospital and statewide metrics that inform daily clinical decision making. The data reported on the clinical dashboard is driven from data sourced from the electronic patient journey board in real time as well as other Queensland Health data sources. This provides clinicians with easy access to a wealth of local unit data presented in a simple graphical format that is being captured locally and arranged on a single screen so the information can be monitored at a glance. Local unit data informs daily decisions that identify and confirm patient flow problems, assist to identify root causes and enable evaluation of patient flow solutions.

  8. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    Science.gov (United States)

    Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

    2012-07-01

    High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

  9. Patient's quality of life after high-dose radiation therapy for thoracic carcinomas. Changes over time and influence on clinical outcome

    International Nuclear Information System (INIS)

    Schroeder, Christina; Engenhart-Cabillic, Rita; Vorwerk, Hilke; Schmidt, Michael; Huhnt, Winfried; Blank, Eyck; Sidow, Dietrich; Buchali, Andre

    2017-01-01

    Quality of life (QoL) is an important factor in patient care. This analysis is focused on QoL before and after radio(chemo)therapy in patients with thoracic carcinomas, as well as on its influence on clinical follow-up and survival, and the correlation with treatment-related toxicities. The analysis included 81 patients with intrathoracic carcinoma receiving radio(chemo)therapy. For analysis of QoL, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the lung cancer-specific supplement (EORTC QLQ-LC13) were used. QoL data were collected before radiation treatment (RT), and 6 weeks, 12 weeks, 6 months, and 12 months after RT. Other factors were additionally analyzed, including clinical outcome, survival, and side effects. The functional scales showed maximum values or at least a recovery 12 weeks after RT. Symptoms with a high mean symptom score (> 40) at all appointments were fatigue, dyspnea, and coughing. Insomnia, peripheral neuropathy, appetite loss, dyspnea (from QLQ-LC13), and all pain parameters had an intermediate mean score (10-40). There were low mean scores of < 10 for nausea and vomiting, diarrhea, sore mouth, and hemoptysis. There was a significant correlation between clinical dysphagia and radiation pneumonitis with the associated symptom scales. None of the QoL scores had a significant influence on local and distant control or survival. 12 weeks after RT the QLQ-C30 functional scales show the highest scores or at least a temporary recovery. The symptom scales accurately reflect the common symptoms and treatment-related toxicities. QoL did not prove to be a significant predictor for local and distant control or survival. (orig.) [de

  10. MR assessment of the repaired rotator cuff: prevalence, size, location, and clinical relevance of tendon rerupture

    International Nuclear Information System (INIS)

    Mellado, J.M.; Calmet, J.; Ballabriga, J.; Gine, J.; Olona, M.; Camins, A.; Perez del Palomar, L.

    2006-01-01

    The objectives of this study were to use magnetic resonance (MR) imaging to evaluate the prevalence, size, location, and clinical relevance of tendon rerupture following complete repair of full-thickness rotator cuff tear (RCT). A total of 78 surgically proven full-thickness rotator cuff tears in 74 patients were retrospectively included in the study. Clinical assessment was performed using the University of California at Los Angeles score. Postoperative MR imaging was evaluated to determine prevalence, size, and location of tendon rerupture. At a mean 48.4 months' follow-up, 62 shoulders (79.5%) had favorable outcomes and 45 shoulders (57.6%) showed rerupture on MR imaging studies. Reruptures were significantly more prevalent among patients with intermediate-to-bad outcomes (81.3%), with surgically demonstrated two-tendon tears (78.9%) or three-tendon tears (100%), and with preoperative fatty degeneration of the supraspinatus muscle greater than 1 (91.6%). Reruptures were also significantly larger in those subgroups. Complete repair of RCT of all sizes may have favorable outcomes in a significant proportion of patients in spite of a high prevalence of reruptures. Preoperative tear size and degree of muscle fatty degeneration influence the prevalence and rerupture size. After repair of supraspinatus tears, reruptures tend to invade the posterior aspect of the tendon. (orig.)

  11. MR assessment of the repaired rotator cuff: prevalence, size, location, and clinical relevance of tendon rerupture

    Energy Technology Data Exchange (ETDEWEB)

    Mellado, J.M. [Hospital Reina Sofia de Tudela, Servicio de Radiodiagnostico, Tudela, Navarra (Spain); Calmet, J.; Ballabriga, J.; Gine, J. [Hospital Universitari de Tarragona Joan XXIII, Servei de Cirurgia Ortopedica i Traumatologia, Tarragona (Spain); Olona, M. [Hospital Universitari de Tarragona Joan XXIII, Servei de Medicina Preventiva i Epidemiologia, Tarragona (Spain); Camins, A. [Hospital Universitari de Tarragona Joan XXIII, Institut de Diagnostic per la Imatge, Tarragona (Spain); Perez del Palomar, L. [Hospital Ernest Lluch, Servicio de Radiologia, Calatayud, Zaragoza (Spain)

    2006-10-15

    The objectives of this study were to use magnetic resonance (MR) imaging to evaluate the prevalence, size, location, and clinical relevance of tendon rerupture following complete repair of full-thickness rotator cuff tear (RCT). A total of 78 surgically proven full-thickness rotator cuff tears in 74 patients were retrospectively included in the study. Clinical assessment was performed using the University of California at Los Angeles score. Postoperative MR imaging was evaluated to determine prevalence, size, and location of tendon rerupture. At a mean 48.4 months' follow-up, 62 shoulders (79.5%) had favorable outcomes and 45 shoulders (57.6%) showed rerupture on MR imaging studies. Reruptures were significantly more prevalent among patients with intermediate-to-bad outcomes (81.3%), with surgically demonstrated two-tendon tears (78.9%) or three-tendon tears (100%), and with preoperative fatty degeneration of the supraspinatus muscle greater than 1 (91.6%). Reruptures were also significantly larger in those subgroups. Complete repair of RCT of all sizes may have favorable outcomes in a significant proportion of patients in spite of a high prevalence of reruptures. Preoperative tear size and degree of muscle fatty degeneration influence the prevalence and rerupture size. After repair of supraspinatus tears, reruptures tend to invade the posterior aspect of the tendon. (orig.)

  12. Establishment of quality assessment standard for mammographic equipment: evaluation of phantom and clinical images

    International Nuclear Information System (INIS)

    Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young

    2005-01-01

    The purpose of this study was to establish a quality standard for mammographic equipment Korea and to eventually improve mammographic quality in clinics and hospitals throughout Korea by educating technicians and clinic personnel. For the phantom test and on site assessment, we visited 37 sites and examined 43 sets of mammographic equipment. Items that were examined include phantom test, radiation dose measurement, developer assessment, etc. The phantom images were assessed visually and by optical density measurements. For the clinical image assessment, clinical images from 371 sites were examined following the new Korean standard for clinical image evaluation. The items examined include labeling, positioning, contrast, exposure, artifacts, collimation among others. Quality standard of mammographic equipment was satisfied in all equipment on site visits. Average mean glandular dose was 114.9 mRad. All phantom image test scores were over 10 points (average, 10.8 points). However, optical density measurements were below 1.2 in 9 sets of equipment (20.9%). Clinical image evaluation revealed appropriate image quality in 83.5%, while images from non-radiologist clinics were adequate in 74.6% (91/122), which was the lowest score of any group. Images were satisfactory in 59.0% (219/371) based on evaluation by specialists following the new Korean standard for clinical image evaluation. Satisfactory images had a mean score of 81.7 (1 S.D. =8.9) and unsatisfactory images had a mean score of 61.9 (1 S.D = 11). The correlation coefficient between the two observers was 0.93 (ρ < 0.01) in 49 consecutive cases. The results of the phantom tests suggest that optical density measurements should be performed as part of a new quality standard for mammographic equipment. The new clinical evaluation criteria that was used in this study can be implemented with some modifications for future mammography quality control by the Korean government

  13. Female Pattern Hair Loss: a clinical and pathophysiological review.

    Science.gov (United States)

    Ramos, Paulo Müller; Miot, Hélio Amante

    2015-01-01

    Female Pattern Hair Loss or female androgenetic alopecia is the main cause of hair loss in adult women and has a major impact on patients' quality of life. It evolves from the progressive miniaturization of follicles that lead to a subsequent decrease of the hair density, leading to a non-scarring diffuse alopecia, with characteristic clinical, dermoscopic and histological patterns. In spite of the high frequency of the disease and the relevance of its psychological impact, its pathogenesis is not yet fully understood, being influenced by genetic, hormonal and environmental factors. In addition, response to treatment is variable. In this article, authors discuss the main clinical, epidemiological and pathophysiological aspects of female pattern hair loss.

  14. The future of monitoring in clinical research - a holistic approach: linking risk-based monitoring with quality management principles.

    Science.gov (United States)

    Ansmann, Eva B; Hecht, Arthur; Henn, Doris K; Leptien, Sabine; Stelzer, Hans Günther

    2013-01-01

    Since several years risk-based monitoring is the new "magic bullet" for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.

  15. High quality mask storage in an advanced Logic-Fab

    Science.gov (United States)

    Jähnert, Carmen; Fritsche, Silvio

    2012-02-01

    High efficient mask logistics as well as safe and high quality mask storage are essential requirements within an advanced lithography area of a modern logic waferfab. Fast operational availability of the required masks at the exposure tool with excellent mask condition requires a safe mask handling, safeguarding of high mask quality over the whole mask usage time without any quality degradation and an intelligent mask logistics. One big challenge is the prevention of haze on high advanced phase shift masks used in a high volume production line for some thousands of 248nm or 193nm exposures. In 2008 Infineon Dresden qualified a customer specific developed semi-bare mask storage system from DMSDynamic Micro Systems in combination with a high advanced mask handling and an interconnected complex logistic system. This high-capacity mask storage system DMS M1900.22 for more than 3000 masks with fully automated mask and box handling as well as full-blown XCDA purge has been developed and adapted to the Infineon Lithotoollandscape using Nikon and SMIF reticle cases. Advanced features for ESD safety and mask security, mask tracking via RFID and interactions with the exposure tools were developed and implemented. The stocker is remote controlled by the iCADA-RSM system, ordering of the requested mask directly from the affected exposure tool allows fast access. This paper discusses the advantages and challenges for this approach as well as the practical experience gained during the implementation of the new system which improves the fab performance with respect to mask quality, security and throughput. Especially the realization of an extremely low and stable humidity level in addition with a well controlled air flow at each mask surface, preventing masks from haze degradation and particle contamination, turns out to be a notable technical achievement. The longterm stability of haze critical masks has been improved significantly. Relevant environmental parameters like

  16. Quality Improvement in Pediatric Endoscopy: A Clinical Report From the NASPGHAN Endoscopy Committee.

    Science.gov (United States)

    Kramer, Robert E; Walsh, Catharine M; Lerner, Diana G; Fishman, Douglas S

    2017-07-01

    The current era of healthcare reform emphasizes the provision of effective, safe, equitable, high-quality, and cost-effective care. Within the realm of gastrointestinal endoscopy in adults, renewed efforts are in place to accurately define and measure quality indicators across the spectrum of endoscopic care. In pediatrics, however, this movement has been less-defined and lacks much of the evidence-base that supports these initiatives in adult care. A need, therefore, exists to help define quality metrics tailored to pediatric practice and provide a toolbox for the development of robust quality improvement (QI) programs within pediatric endoscopy units. Use of uniform standards of quality reporting across centers will ensure that data can be compared and compiled on an international level to help guide QI initiatives and inform patients and their caregivers of the true risks and benefits of endoscopy. This report is intended to provide pediatric gastroenterologists with a framework for the development and implementation of endoscopy QI programs within their own centers, based on available evidence and expert opinion from the members of the NASPGHAN Endoscopy Committee. This clinical report will require expansion as further research pertaining to endoscopic quality in pediatrics is published.

  17. Brief report: Inhibitory control of socially relevant stimuli in children with high functioning autism

    NARCIS (Netherlands)

    Geurts, H.M.; Begeer, S.; Stockman, L.

    2009-01-01

    The current study explored whether inhibitory control deficits in high functioning autism (HFA) emerged when socially relevant stimuli were used and whether arousal level affected the performance. A Go/NoGo paradigm, with socially relevant stimuli and varying presentation rates, was applied in 18

  18. Prognostic Relevance of Immunohistochemical Subclassification of Diffuse Large B-Cell Lymphoma in Two Prospective Phase III Clinical Trials

    NARCIS (Netherlands)

    Rayman, Nazik; Lam, King H.; van der Holt, Bronno; Koss, Clara; Veldhuizen, Dennis; Budel, Leo M.; Mulder, Andries H.; Verdonck, Leo F.; Delwel, Ruud; de Jong, Daphne; van Imhoff, Gustaaf W.; Sonneveld, Pieter

    Purpose: Until now molecular biologic techniques have not been easily used in daily clinical practice to stratify patients for therapeutic purposes. Therefore, we have investigated the prognostic relevance of the immunohistochemical (IHC) germinal center B-cell (GCB) versus non-GCB diffuse large

  19. What are the effective ways to translate clinical leadership into health care quality improvement?

    Science.gov (United States)

    McSherry, Robert; Pearce, Paddy

    2016-01-01

    The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks.

  20. Importance of customer adjustment regions in the non-clinical property of thought: A home examination in low and high-income areas of Mashhad.

    Science.gov (United States)

    Fazaeli, S; Yousefi, M; Banikazemi, S H; Ghazizadeh Hashemi, Sah; Khorsand, A; Badiee, Sh

    2015-01-01

    Responsiveness was proposed via WHO as a fundamental sign to evaluate the enforcement of wellness practices and evaluates with a standard organization of fields that are classified to 2 principal classes "Respect as characters" and "customer adjustment". The current research included the value of customer adjustment areas in low and high-income communities of Mashhad. In the current descriptive research, an example of 923 families was chosen stochastically of 2 low and high pay areas of Mashhad. WHO survey employed for information gathering. Regular rate reviews and Ordinal Logistic Regression (OLR) applied for information investigation. In overall, respondents chose basic amenities quality as the primary area, and the path to social care networks recognized as the wicked primary area. Families in high-income states obtained higher areas of immediate notations and selection associated with low-income. There is a meaningful correlation among parameters of ages, having a part whom required care and self-imposed health via the ranking of customer adjustment areas. The investigation of the homes' viewpoint concerning the classification of non-clinical perspectives of care quality, particularly while confronted by restricted sources, can assist in managing enterprises towards topics that are more relevant and results in the development of the wellness policy achievement and fecundity.

  1. Comparative analysis of three drug-drug interaction screening systems against probable clinically relevant drug-drug interactions: a prospective cohort study.

    Science.gov (United States)

    Muhič, Neža; Mrhar, Ales; Brvar, Miran

    2017-07-01

    Drug-drug interaction (DDI) screening systems report potential DDIs. This study aimed to find the prevalence of probable DDI-related adverse drug reactions (ADRs) and compare the clinical usefulness of different DDI screening systems to prevent or warn against these ADRs. A prospective cohort study was conducted in patients urgently admitted to medical departments. Potential DDIs were checked using Complete Drug Interaction®, Lexicomp® Online™, and Drug Interaction Checker®. The study team identified the patients with probable clinically relevant DDI-related ADRs on admission, the causality of which was assessed using the Drug Interaction Probability Scale (DIPS). Sensitivity, specificity, and positive and negative predictive values of screening systems to prevent or warn against probable DDI-related ADRs were evaluated. Overall, 50 probable clinically relevant DDI-related ADRs were found in 37 out of 795 included patients taking at least two drugs, most common of them were bleeding, hyperkalemia, digitalis toxicity, and hypotension. Complete Drug Interaction showed the best sensitivity (0.76) for actual DDI-related ADRs, followed by Lexicomp Online (0.50), and Drug Interaction Checker (0.40). Complete Drug Interaction and Drug Interaction Checker had positive predictive values of 0.07; Lexicomp Online had 0.04. We found no difference in specificity and negative predictive values among these systems. DDI screening systems differ significantly in their ability to detect probable clinically relevant DDI-related ADRs in terms of sensitivity and positive predictive value.

  2. Transferring Aviation Practices into Clinical Medicine for the Promotion of High Reliability.

    Science.gov (United States)

    Powell-Dunford, Nicole; McPherson, Mark K; Pina, Joseph S; Gaydos, Steven J

    2017-05-01

    Aviation is a classic example of a high reliability organization (HRO)-an organization in which catastrophic events are expected to occur without control measures. As health care systems transition toward high reliability, aviation practices are increasingly transferred for clinical implementation. A PubMed search using the terms aviation, crew resource management, and patient safety was undertaken. Manuscripts authored by physician pilots and accident investigation regulations were analyzed. Subject matter experts involved in adoption of aviation practices into the medical field were interviewed. A PubMed search yielded 621 results with 22 relevant for inclusion. Improved clinical outcomes were noted in five research trials in which aviation practices were adopted, particularly with regard to checklist usage and crew resource-management training. Effectiveness of interventions was influenced by intensity of application, leadership involvement, and provision of staff training. The usefulness of incorporating mishap investigation techniques has not been established. Whereas aviation accident investigation is highly standardized, the investigation of medical error is characterized by variation. The adoption of aviation practices into clinical medicine facilitates an evolution toward high reliability. Evidence for the efficacy of the checklist and crew resource-management training is robust. Transference of aviation accident investigation practices is preliminary. A standardized, independent investigation process could facilitate the development of a safety culture commensurate with that achieved in the aviation industry.Powell-Dunford N, McPherson MK, Pina JS, Gaydos SJ. Transferring aviation practices into clinical medicine for the promotion of high reliability. Aerosp Med Hum Perform. 2017; 88(5):487-491.

  3. Clinically relevant radioresistant cells efficiently repair DNA double-strand breaks induced by X-rays

    International Nuclear Information System (INIS)

    Kuwahara, Yoshikazu; Baba, Taisuke; Nakagawa, Hironobu; Shimura, Tsutomu; Yamamoto, Yoichiro; Fukumoto, Manabu; Li Li; Ohkubo, Yasuhito

    2009-01-01

    Radiotherapy is one of the major therapeutic modalities for eradicating malignant tumors. However, the existence of radioresistant cells remains one of the most critical obstacles in radiotherapy and radiochemotherapy. Standard radiotherapy for tumor treatment consists of approximately 2 Gy once a day, 5 days a week, over a period of 5-8 weeks. To understand the characteristics of radioresistant cells and to develop more effective radiotherapy, we established a novel radioresistant cell line, HepG2-8960-R with clinical relevance from parental HepG2 cells by long-term fractionated exposure to 2 Gy of X-rays. HepG2-8960-R cells continued to proliferate with daily exposure to 2 Gy X-rays for more than 30 days, while all parental HepG2 cells ceased. After exposure to fractionated 2 Gy X-rays, induction frequencies of micronuclei and remaining foci of γ-H2AX in HepG2-8960-R were less than those in HepG2. Flow cytometric analysis revealed that the proportion of cells in S- and G2/M-phase of the cell cycle was higher in HepG2-8960-R than in HepG2. These suggest that the response of clinically relevant radioresistant (CRR) cells to fractionated radiation is not merely an accumulated response to each fractionated radiation. This is the first report on the establishment of a CRR cell line from an isogenic parental cell line. (author)

  4. Clinical Empathy and Narrative Competence: The Relevance of Reading Talmudic Legends as Literary Fiction

    Directory of Open Access Journals (Sweden)

    John H. Davidson

    2015-04-01

    Full Text Available The “curative potential” in almost any clinical setting depends on a caregiver establishing and maintaining an empathic connection with patients so as to achieve “narrative competence” in discerning and acting in accord with their preferences and best interests. The “narrative medicine” model of shared “close reading of literature and reflective writing” among clinicians as a means of fostering a capacity for clinical empathy has gained validation with recent empirical studies demonstrating the enhancement of theory of mind (ToM, broadly conceived as empathy, in readers of literary fiction. Talmudic legends, like that of Rabbi Judah’s death, are under-appreciated, relevant sources of literary fiction for these efforts. The limitations of narrative medicine are readily counterbalanced by simultaneously practiced attention to traditional bioethical principles, including—especially—beneficence, non-maleficence, and autonomy.

  5. MR imaging of the articular cartilage of the knee with arthroscopy as gold standard: assessment of methodological quality of clinical studies

    International Nuclear Information System (INIS)

    Duchateau, Florence; Berg, Bruno C. vande

    2002-01-01

    The purpose of this study was to assess the methodological quality of articles addressing the value of MR imaging of the knee cartilage with arthroscopy as a standard. Relevant papers were selected after Medline review (MEDLINE database search including the terms ''cartilage'' ''knee'', ''MR'' and ''arthroscopy''). Two observers reviewed independently 29 selected articles to determine how each study had met 15 individual standards that had been previously developed to assess the methodological quality of clinical investigations. The following criteria were met in variable percentage of articles including adequate definition of purpose (100%), statistical analysis (90%), avoidance of verification bias (86%), patient population description (83%), reference standard (79%), review bias (79%), study design (66%), inclusion criteria (41%) and method of analysis (41.5%), avoidance of diagnostic-review bias (24%), exclusion criteria (21%), indeterminate examination results (17%), analysis criteria (14%), interobserver reliability (14%) and intraobserver reliability (7%). The assessment of the methodological quality of clinical investigations addressing the value of MR imaging in the evaluation of the articular cartilage of the knee with arthroscopy as the standard of reference demonstrated that several standards were rarely met in the literature. Efforts should be made to rely on clearly defined lesion criteria and to determine reliability of the observations. (orig.)

  6. Quality of COPD care in hospital outpatient clinics in Denmark: The KOLIBRI study

    DEFF Research Database (Denmark)

    Lange, P.; Andersen, Klaus Kaae; Munch, E.

    2009-01-01

    of the hospital records one year apart before and after the educational programme for the participating doctors and nurses. A total of 941 patient records were included in the first audit and 927 in the second. The indicators of quality of care comprised amongst others referral to pulmonary rehabilitation......Background: We studied the quality of care for COPD patients in 22 hospital-based outpatient clinics in Denmark and evaluated if participation by the staff in an educational programme could improve the quality of care and adherence to the COPD guidelines. Methods: We performed two audits...... by focusing on a more systematic approach to the patient assessment by education of the staff of the outpatient clinics. A repeated and continuous education and discussion with the clinical staff is probably essential to reach an acceptable level of the quality of care for outpatients with COPD....

  7. Quality Management and Key Performance Indicators in Oncologic Esophageal Surgery.

    Science.gov (United States)

    Gockel, Ines; Ahlbrand, Constantin Johannes; Arras, Michael; Schreiber, Elke Maria; Lang, Hauke

    2015-12-01

    Ranking systems and comparisons of quality and performance indicators will be of increasing relevance for complex "high-risk" procedures such as esophageal cancer surgery. The identification of evidence-based standards relevant for key performance indicators in esophageal surgery is essential for establishing monitoring systems and furthermore a requirement to enhance treatment quality. In the course of this review, we analyze the key performance indicators case volume, radicality of resection, and postoperative morbidity and mortality, leading to continuous quality improvement. Ranking systems established on this basis will gain increased relevance in highly complex procedures within the national and international comparison and furthermore improve the treatment of patients with esophageal carcinoma.

  8. College clinic service quality and patient satisfaction.

    Science.gov (United States)

    Deshwal, Pankaj; Ranjan, Vini; Mittal, Geetika

    2014-01-01

    The purpose of this paper is to identify the service quality dimensions that play an important role in patient satisfaction in campus clinics in Delhi; assess student satisfaction with service; and suggests ways to improve areas of dissatisfaction. A questionnaire was distributed to students who had completed at least two consultations at the college clinic. Convenience sampling was used to approach respondents. The questionnaire uses modified SERVQUAL and other instruments, including original dimensions and those constructed through detailed discussions. Factor analyses, reliability tests and the Kaiser-Meyer-Olkin measure of sampling adequacy were conducted. The final sample had a total of 445 respondents. After factor analysis, the authors found that the dimensions affecting patient satisfaction are: staff professionalism; clinic staff reliability; clinic accessibility and basic facilities; tangibles; cleanliness; awareness of the clinic/diseases and how clinic staff deals with emergencies. Most students were satisfied with the professionalism of the clinic staff. More than 70 percent of the respondents reported that the clinic staff paid good attention to them. The campus clinic was deemed reliable by more than 50 percent of respondents. The students found the clinic's location convenient, with more than 50 percent supporting its location. However, there was dissatisfaction among the students regarding the tangibles of the clinic, with more than 50 percent favoring upgrading. There was satisfaction among the respondents regarding the availability of the doctor after clinic hours, but contact details for the clinic staff were not easily accessible on campus. More than 60 percent of respondents were satisfied with the cleanliness of the campus clinic. More than 50 percent felt that the campus clinic was not equipped to deal with emergencies efficiently. At the same time, 90 percent of respondents reported the availability of referral facilities in case of

  9. Clinical efficiency, image quality and dosimetric considerations

    Energy Technology Data Exchange (ETDEWEB)

    Arreola, M. [Director of Clinical Radiological Physics, Shands Hospital at the University of Florida College of Medicine, Gainesville, FL (United States)

    2000-07-01

    Three decades have passed since the first clinical use of the famous EMI Computed Axial Tomography (Cat) scanner. At the time, the prospects for clinical success of this innovative idea were not very good. Time, however, has proven otherwise as what is now simply known as Computed tomography (CT) has been boosted in each one of these decades for different reasons. In the 1970s, technological progress augmented by the realization of the importance of tomographic imaging got everything started; in the 1980s, the boom in health care demand in the US solidified its position and in the 1990s the technological explosion in computers and the imperative need to lower costs in the health care industry have prompted the most dramatic changes in the wy CT is utilized in the year 2000. Thus, different motivations have led the way of progress in CT at various times, and in spite of amazing developments in other crucial imaging modalities, such as ultrasound, Doppler ultrasound, digital subtraction angiography and magnetic resonance imaging, CT maintains its rightful place as the premiere imaging modality in the modern radiology department. This work covers the basic principles of tomographic image reconstruction, and how axial CT scanners progressed historically in the first two decades. Developments in X-ray tubes, and detection systems are highlighted, as well as the impact of clinical efficiency, image quality and patient doses. The basic construction of translate-rotate (1st and 2nd generation), rotate-rotate (3rd generation) and detector ring (4th generation) scanners are described. The so-called 5th generation scanner, the electron beam scanner, is also described, with its clinical and technical advantages and its inherent financial and maintenance disadvantages, which brought the advent of spiral and multi-slice scanners. These most recent developments in CT technology have opened a new era in the clinical use of CT; and although image quality has reached an expected

  10. Clinical efficiency, image quality and dosimetric considerations

    International Nuclear Information System (INIS)

    Arreola, M.

    2000-01-01

    Three decades have passed since the first clinical use of the famous EMI Computed Axial Tomography (Cat) scanner. At the time, the prospects for clinical success of this innovative idea were not very good. Time, however, has proven otherwise as what is now simply known as Computed tomography (CT) has been boosted in each one of these decades for different reasons. In the 1970s, technological progress augmented by the realization of the importance of tomographic imaging got everything started; in the 1980s, the boom in health care demand in the US solidified its position and in the 1990s the technological explosion in computers and the imperative need to lower costs in the health care industry have prompted the most dramatic changes in the wy CT is utilized in the year 2000. Thus, different motivations have led the way of progress in CT at various times, and in spite of amazing developments in other crucial imaging modalities, such as ultrasound, Doppler ultrasound, digital subtraction angiography and magnetic resonance imaging, CT maintains its rightful place as the premiere imaging modality in the modern radiology department. This work covers the basic principles of tomographic image reconstruction, and how axial CT scanners progressed historically in the first two decades. Developments in X-ray tubes, and detection systems are highlighted, as well as the impact of clinical efficiency, image quality and patient doses. The basic construction of translate-rotate (1st and 2nd generation, rotate-rotate (3rd generation) and detector ring (4th generation) scanners are described. The so-called 5th generation scanner, the electron beam scanner, is also described, with its clinical and technical advantages and its inherent financial and maintenance disadvantages, which brought the advent of spiral and multi-slice scanners. These most recent developments in CT technology have opened a new era in the clinical use of CT; and although image quality has reached an expected

  11. Refeeding syndrome: clinical and nutritional relevance.

    Science.gov (United States)

    Viana, Larissa de Andrade; Burgos, Maria Goretti Pessoa de Araújo; Silva, Rafaella de Andrade

    2012-01-01

    Feedback syndrome is characterized clinically by neurological alterations, respiratory symptoms, arrhythmias and heart failure few days after refeeding. It happens due to severe electrolyte changes, such as hypophosphatemia, hypomagnesemia and hypokalemia associated with metabolic abnormalities that may occur as a result of nutritional support (oral, enteral or parenteral) in severely malnourished patients. To evaluate its causes and the preventive dietary measures aiming to reduce the morbimortality. Was conducted literature review in SciELO, LILACS, Medline / PUBMED, Cochrane Library and government websites in Portuguese, English and Spanish. The survey was about the last 15 years, selecting the headings: refeeding syndrome, malnutrition, hypophosphatemia, hypokalemia, hypomagnesemia. The monitoring of metabolic parameters and electrolyte levels before starting nutritional support and periodically during feeding should be based on protocols and the duration of therapy. Patients at high risk and other metabolic complications should be followed closely, and depletion of minerals and electrolytes should be replaced before starting the diet. A multidisciplinary team of nutrition therapy can guide and educate other health professionals in prevention, diagnosis and treatment of the syndrome.

  12. High-quality compressive ghost imaging

    Science.gov (United States)

    Huang, Heyan; Zhou, Cheng; Tian, Tian; Liu, Dongqi; Song, Lijun

    2018-04-01

    We propose a high-quality compressive ghost imaging method based on projected Landweber regularization and guided filter, which effectively reduce the undersampling noise and improve the resolution. In our scheme, the original object is reconstructed by decomposing of regularization and denoising steps instead of solving a minimization problem in compressive reconstruction process. The simulation and experimental results show that our method can obtain high ghost imaging quality in terms of PSNR and visual observation.

  13. A clinical distance measure for evaluating treatment plan quality difference with Pareto fronts in radiotherapy

    Directory of Open Access Journals (Sweden)

    Kristoffer Petersson

    2017-07-01

    Full Text Available We present a clinical distance measure for Pareto front evaluation studies in radiotherapy, which we show strongly correlates (r = 0.74 and 0.90 with clinical plan quality evaluation. For five prostate cases, sub-optimal treatment plans located at a clinical distance value of >0.32 (0.28–0.35 from fronts of Pareto optimal plans, were assessed to be of lower plan quality by our (12 observers (p < .05. In conclusion, the clinical distance measure can be used to determine if the difference between a front and a given plan (or between different fronts corresponds to a clinically significant plan quality difference.

  14. The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage.

    Science.gov (United States)

    Panzitta, Michele; Ponti, Mauro; Bruno, Giorgio; Cois, Giancarlo; D'Arpino, Alessandro; Minghetti, Paola; Mendicino, Francesca Romana; Perioli, Luana; Ricci, Maurizio

    2017-01-10

    Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Does a research article's country of origin affect perception of its quality and relevance? A national trial of US public health researchers.

    Science.gov (United States)

    Harris, M; Macinko, J; Jimenez, G; Mahfoud, M; Anderson, C

    2015-12-30

    The source of research may influence one's interpretation of it in either negative or positive ways, however, there are no robust experiments to determine how source impacts on one's judgment of the research article. We determine the impact of source on respondents' assessment of the quality and relevance of selected research abstracts. Web-based survey design using four healthcare research abstracts previously published and included in Cochrane Reviews. All Council on the Education of Public Health-accredited Schools and Programmes of Public Health in the USA. 899 core faculty members (full, associate and assistant professors) Each of the four abstracts appeared with a high-income source half of the time, and low-income source half of the time. Participants each reviewed the same four abstracts, but were randomly allocated to receive two abstracts with high-income source, and two abstracts with low-income source, allowing for within-abstract comparison of quality and relevance Within-abstract comparison of participants' rating scores on two measures--strength of the evidence, and likelihood of referral to a peer (1-10 rating scale). OR was calculated using a generalised ordered logit model adjusting for sociodemographic covariates. Participants who received high income country source abstracts were equal in all known characteristics to the participants who received the abstracts with low income country sources. For one of the four abstracts (a randomised, controlled trial of a pharmaceutical intervention), likelihood of referral to a peer was greater if the source was a high income country (OR 1.28, 1.02 to 1.62, pincome source in their rating of research abstracts. More research may be needed to explore how the origin of a research article may lead to stereotype activation and application in research evaluation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  16. What are the effective ways to translate clinical leadership into health care quality improvement?

    Directory of Open Access Journals (Sweden)

    McSherry R

    2016-02-01

    Full Text Available Robert McSherry,1 Paddy Pearce2 1School of Health and Social Care, University of Teesside, Middlesbrough, 2PKP Consulting, Yarm, United Kingdom Abstract: The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks. Keywords: governance

  17. Leveraging a Redesigned Morbidity and Mortality Conference That Incorporates the Clinical and Educational Missions of Improving Quality and Patient Safety.

    Science.gov (United States)

    Tad-Y, Darlene B; Pierce, Read G; Pell, Jonathan M; Stephan, Lindsie; Kneeland, Patrick P; Wald, Heidi L

    2016-09-01

    The morbidity and mortality (M&M) conference is a vital event that can affect medical education, quality improvement, and peer review in academic departments. Historically, M&M conferences have emphasized cases that highlight diagnostic uncertainty or complex management conundrums. In this report, the authors describe the development, pilot, and refinement of a systems-based M&M conference model that combines the educational and clinical missions of improving quality and patient safety in the University of Colorado Department of Medicine. In 2011, a focused taskforce completed a literature review that informed the development of a framework for the redesigned systems-based M&M conference. The new model included a restructured monthly conference, longitudinal curriculum for residents, and formal channels for interaction with clinical effectiveness departments. Each conference features an in-depth discussion of an adverse event using specific quality improvement tools. Areas for improvement and suggested action items are identified during the conference and delegated to the relevant clinical departments. The new process has enabled the review of 27 adverse events over two years. Sixty-three action items were identified, and 33 were pursued. An average of 50 to 60 individuals participate in each conference, including interprofessional and interdisciplinary colleagues. Resident and faculty feedback regarding the new format has been positive, and other departments are starting to adopt this model. A more robust process for identifying and selecting cases to discuss is needed, as is a stable, sufficient mechanism to manage the improvement initiatives that come out of each conference.

  18. Using health care audit to improve quality of clinical records: the preliminary experience of an Italian Cancer Institute.

    Science.gov (United States)

    Cadeddu, Chiara; Specchia, Maria Lucia; Cacciatore, Pasquale; Marchini, Raffaele; Ricciardi, Walter; Cavuto, Costanza

    2017-01-01

    Audit and feedback are recognized as part of a strategy for improving performance and supporting quality and safety in European health care systems. These considerations led the Clinical Management Staff of the "Regina Elena" Italian Cancer Institute to start a project of self-assessment of the quality of clinical records and organizational appropriateness through a retrospective review. The evaluation about appropriateness and congruity concerned both clinical records of 2013 and of 2015. At the end of the assessment of clinical records of each Care Unit, results were shared with medical staff in scheduled audit meetings. One hundred and thirteen clinical records (19%) did not meet congruity criteria, while 74 (12.6%) resulted as inappropriate. Considering the economic esteem calculated from the difference between Diagnosis Related Groups (DRG) primarily identified as main diagnosis and main surgical intervention or procedure and those modified during the Local Health Unit (LHU) assessment, 2 surgical Care Units produced a high negative difference in terms of economic value with a consequent drop of hospital discharge form (named in Italian "scheda di dimissione ospedaliera", SDO) remuneration, 7 Care Units produced about the same medium difference with almost no change as SDO remuneration, and 2 Care Units had a positive difference with a profit in terms of SDO remuneration. Concerning the quality assessment of clinical records of 2015, the most critical areas were related to medical documents and hospital discharge form compilation. Our experience showed the effectiveness of clinical audit in assessing the quality of filling in medical records and the appropriateness of hospital admissions and the acceptability of this tool by clinicians.

  19. Clinical Relevance of HLA Gene Variants in HBV Infection

    Directory of Open Access Journals (Sweden)

    Li Wang

    2016-01-01

    Full Text Available Host gene variants may influence the natural history of hepatitis B virus (HBV infection. The human leukocyte antigen (HLA system, the major histocompatibility complex (MHC in humans, is one of the most important host factors that are correlated with the clinical course of HBV infection. Genome-wide association studies (GWASs have shown that single nucleotide polymorphisms (SNPs near certain HLA gene loci are strongly associated with not only persistent HBV infection but also spontaneous HBV clearance and seroconversion, disease progression, and the development of liver cirrhosis and HBV-related hepatocellular carcinoma (HCC in chronic hepatitis B (CHB. These variations also influence the efficacy of interferon (IFN and nucleot(side analogue (NA treatment and response to HBV vaccines. Meanwhile, discrepant conclusions were reached with different patient cohorts. It is therefore essential to identify the associations of specific HLA allele variants with disease progression and viral clearance in chronic HBV infection among different ethnic populations. A better understanding of HLA polymorphism relevance in HBV infection outcome would enable us to elucidate the roles of HLA SNPs in the pathogenesis and clearance of HBV in different areas and ethnic groups, to improve strategies for the prevention and treatment of chronic HBV infection.

  20. Methodology of clinical measures of healthcare quality delivered to patients with cardiovascular diseases

    Directory of Open Access Journals (Sweden)

    Posnenkova O.M.

    2014-03-01

    Full Text Available The results of implementation the methodology proposed by American Colleague of Cardiology and American Heart Association (ACC/AHA for development of Russian clinical quality measures for patients with arterial hypertension, coronary heart disease and chronic heart failure. Created quality measures cover the key elements of medical care influencing directly on clinical outcomes of treatment.

  1. The STAR Data Reporting Guidelines for Clinical High Altitude Research.

    Science.gov (United States)

    Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken

    2018-03-01

    Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

  2. Patient-reported assessment of quality care at end of life: development and validation of Quality Care Questionnaire-End of Life (QCQ-EOL).

    Science.gov (United States)

    Yun, Young Ho; Kim, Soo-Hyun; Lee, Kyoung-Min; Park, Sang Min; Lee, Chang Geol; Choi, Youn Seon; Lee, Won Sup; Kim, Si-Young; Heo, Dae Seog

    2006-09-01

    Our goal was to validate an instrument with which terminally ill patients could evaluate the quality of care they receive at the end of life (EOL). Questionnaire development followed a four-phase process: item generation and reduction, construction, pilot testing, and field-testing. Using relevance and priority criteria and pilot testing, we developed a 16-item questionnaire. Factor analyses of data from 235 patients resulted in the Quality Care Questionnaire-End of Life (QCQ-EOL) covering dignity-conserving care, care by health care professionals, individualised care, and family relationships. All subscales and total scores showed high internal consistency (Cronbach alpha range, 0.73-0.89). The ability of total score and selective subscale scores clearly differentiated patients on the basis of clinical situation, sense of dignity, and general rating of care quality. Correlations of scores between patients and caregivers were substantial. The QCQ-EOL can be adopted to assess the quality of care received by terminally ill patients.

  3. Effect of specific or random c-DNA priming on sensitivity of tyrosinase nested RT-PCR : Potential clinical relevance

    NARCIS (Netherlands)

    Calogero, A; Hospers, GAP; Timmer-Bosscha, H; Mulder, NH; Schraffordt Koops, H.

    2000-01-01

    The reverse transcriptase polymerase chain reaction (RT-PCR) can be of clinical relevance in identifying malignant melanoma cells in blood or tissues of patients at risk for disseminated melanoma. The diagnostic value of this marker however, is still controversial. The objective of this study was to

  4. Why quality of life measurement is important in dermatology clinical practice

    DEFF Research Database (Denmark)

    Finlay, A Y; Salek, M S; Abeni, D

    2017-01-01

    The aim of this study was to describe the many ways in which quality of life (QoL) measurement may potentially be advantageous in routine clinical dermatology practice. Thirteen members of the EADV Task Force on Quality of Life, eight dermatologists, three health psychologists, one epidemiologist...

  5. Providing high-quality care in primary care settings: how to make trade-offs.

    Science.gov (United States)

    Beaulieu, Marie-Dominique; Geneau, Robert; Del Grande, Claudio; Denis, Jean-Louis; Hudon, Eveline; Haggerty, Jeannie L; Bonin, Lucie; Duplain, Réjean; Goudreau, Johanne; Hogg, William

    2014-05-01

    To gain a deeper understanding of how primary care (PC) practices belonging to different models manage resources to provide high-quality care. Multiple-case study embedded in a cross-sectional study of a random sample of 37 practices. Three regions of Quebec. Health care professionals and staff of 5 PC practices. Five cases showing above-average results on quality-of-care indicators were purposefully selected to contrast on region, practice size, and PC model. Data were collected using an organizational questionnaire; the Team Climate Inventory, which was completed by health care professionals and staff; and 33 individual interviews. Detailed case histories were written and thematic analysis was performed. The core common feature of these practices was their ongoing effort to make trade-offs to deliver services that met their vision of high-quality care. These compromises involved the same 3 areas, but to varying degrees depending on clinic characteristics: developing a shared vision of high-quality care; aligning resource use with that vision; and balancing professional aspirations and population needs. The leadership of the physician lead was crucial. The external environment was perceived as a source of pressure and dilemmas rather than as a source of support in these matters. Irrespective of their models, PC practices' pursuit of high-quality care is based on a vision in which accessibility is a key component, balanced by appropriate management of available resources and of external environment expectations. Current PC reforms often create tensions rather than support PC practices in their pursuit of high-quality care. Copyright© the College of Family Physicians of Canada.

  6. Clinical relevance of surgical site infection as defined by the criteria of the Centers for Disease Control and Prevention

    DEFF Research Database (Denmark)

    Henriksen, N A; Meyhoff, C S; Wetterslev, J

    2010-01-01

    Surgical site infection (SSI) is a common complication after abdominal surgery and the Centers for Disease Control and Prevention (CDC) criteria are commonly used for diagnosis and surveillance. The aim of this study was to evaluate whether SSI diagnosed according to CDC is clinically relevant...... diagnosed with SSI and a matched control group (N=46) without SSI according to the CDC criteria after laparotomy. Two blinded experienced surgeons evaluated the hospital records and determined whether patients had CRSSI, based on the following criteria: antibiotic treatment, surgical intervention, prolonged...... hospital stay or referral to an intensive care unit for SSI. The rate of CRSSI was 38 of 54 (70%) in patients with CDC-diagnosed SSI and none in patients without a CDC-diagnosed SSI. Sixty-one percent of the CDC-diagnosed SSIs were superficial, of which 48% were considered clinically relevant...

  7. Fabrication of high-quality brazed joints

    International Nuclear Information System (INIS)

    Orlov, A.V.

    1980-01-01

    Problem of ensuring of joint high-quality when brazing different parts in power engineering is considered. To obtain high-quality joints it is necessary to correctly design brazed joint and to choose a gap width, overlap length and fillet radius; to clean up carefully the surfaces to be brazed and fix them properly one relative to another; to apply a solder so as to provide its flowing into the gap and sticking in it; to exactly regulate thermal conditions of brazing. High quality and reliability of brazed joints are ensured by the application of solders based on noble metals, and cheap solders based on nickel, manganese and copper. Joints brazed with nickel base solders may operate at temperatures as high as 888 deg C

  8. Mechanism of Action of Prostate Stem Cell Antigen Targeted Antibody Therapy and its Relevance to Clinical Application in Prostate Cancer

    National Research Council Canada - National Science Library

    Reiter, Robert; Tran, Chau

    2008-01-01

    .... A better understanding of PSCA function and its antibody activity will enable rational patient selection and trial design all of which are particularly relevant to subsequent clinical trials of PSCA antibody...

  9. Mechanism of Action of Prostate Stem Cell Antigen Targeted Antibody Therapy and Its Relevance to Clinical Application in Prostate Cancer

    National Research Council Canada - National Science Library

    Reiter, Robert; Tran, Chau

    2007-01-01

    .... A better understanding of PSCA function and its antibody activity will enable rational patient selection and trial design, all of which are particularly relevant to subsequent clinical trials of PSCA antibody...

  10. Using an Ishikawa diagram as a tool to assist memory and retrieval of relevant medical cases from the medical literature.

    Science.gov (United States)

    Wong, Kam Cheong

    2011-03-29

    Studying medical cases is an effective way to enhance clinical reasoning skills and reinforce clinical knowledge. An Ishikawa diagram, also known as a cause-and-effect diagram or fishbone diagram, is often used in quality management in manufacturing industries.In this report, an Ishikawa diagram is used to demonstrate how to relate potential causes of a major presenting problem in a clinical setting. This tool can be used by teams in problem-based learning or in self-directed learning settings.An Ishikawa diagram annotated with references to relevant medical cases and literature can be continually updated and can assist memory and retrieval of relevant medical cases and literature. It could also be used to cultivate a lifelong learning habit in medical professionals.

  11. Using an Ishikawa diagram as a tool to assist memory and retrieval of relevant medical cases from the medical literature

    Directory of Open Access Journals (Sweden)

    Wong Kam Cheong

    2011-03-01

    Full Text Available Abstract Studying medical cases is an effective way to enhance clinical reasoning skills and reinforce clinical knowledge. An Ishikawa diagram, also known as a cause-and-effect diagram or fishbone diagram, is often used in quality management in manufacturing industries. In this report, an Ishikawa diagram is used to demonstrate how to relate potential causes of a major presenting problem in a clinical setting. This tool can be used by teams in problem-based learning or in self-directed learning settings. An Ishikawa diagram annotated with references to relevant medical cases and literature can be continually updated and can assist memory and retrieval of relevant medical cases and literature. It could also be used to cultivate a lifelong learning habit in medical professionals.

  12. Echography of clinically relevant disorders in the genital tract of female dromedary camels.

    Science.gov (United States)

    Ali, Ahmed; Derar, Derar; Alsamri, Ali; Al Sobayil, Fahd

    2017-07-01

    The aim of this study was to characterize the clinically relevant genital tract disorders of dromedary camels. Reproductive tract examinations were performed via transrectal palpation, ultrasonography and vaginal exploration. The ultrasonic appearance of the reproductive pathology was described and compared with its morphology at laparotomy, after surgical removal, during postmortem examination or upon slaughter. Diagnosis was also confirmed by histopathology. The most frequently encountered follicular structures were larger than typical follicles (56/338, 16.6%) having three echo textures: 1) thin walls and clear hyperechogenic content (11.6%); 2) thick walls and few fibrous trabeculae (33.7%); and 3) thick walls and many echogenic transecting fibrinous strands (54.7%). Corpora lutea with non-echoic central cavity (5/31, 16.1%) were greater in diameter than those with no cavity (26/31, 83.9%) (P=0.03). A granulosa cell tumor (1/338, 0.3%) was multilocular and honeycombed in shape. Presence of a large, well-demarcated, hypoechogenic sac lateral to or beneath the uterine horn encasing the ovary was diagnostic for ovarian hydrobursitis (102/338, 30.2%). Hydrosalpinx and pyosalpinx (6/338, 1.8%) were beaded in appearance, with the ovary located outside these structures. Clinical endometritis/cervicitis (122, 36.1%) was characterized by changes in the homogeneity in about half of the cases. A greatly dilated uterus with clear, hypoechogenic or echogenic contents with signs of hydrometra and pyometra, respectively, was another categorization of a reproductive pathology (24/338, 7.1%). Highly reflective, linear structures were observed in cases with intrauterine fetal bone retention (1/338, 0.3%). In conclusion, reproductive pathologies in dromedary camels can be efficiently imaged by use of ultrasonic technologies, thus familiarizing the practitioner with these disorders and facilitating application of these technologies so that suitable treatment can occur is important

  13. The clinical relevance of advanced artificial feedback in the control of a multi-functional myoelectric prosthesis.

    Science.gov (United States)

    Markovic, Marko; Schweisfurth, Meike A; Engels, Leonard F; Bentz, Tashina; Wüstefeld, Daniela; Farina, Dario; Dosen, Strahinja

    2018-03-27

    To effectively replace the human hand, a prosthesis should seamlessly respond to user intentions but also convey sensory information back to the user. Restoration of sensory feedback is rated highly by the prosthesis users, and feedback is critical for grasping in able-bodied subjects. Nonetheless, the benefits of feedback in prosthetics are still debated. The lack of consensus is likely due to the complex nature of sensory feedback during prosthesis control, so that its effectiveness depends on multiple factors (e.g., task complexity, user learning). We evaluated the impact of these factors with a longitudinal assessment in six amputee subjects, using a clinical setup (socket, embedded control) and a range of tasks (box and blocks, block turn, clothespin and cups relocation). To provide feedback, we have proposed a novel vibrotactile stimulation scheme capable of transmitting multiple variables from a multifunction prosthesis. The subjects wore a bracelet with four by two uniformly placed vibro-tactors providing information on contact, prosthesis state (active function), and grasping force. The subjects also completed a questionnaire for the subjective evaluation of the feedback. The tests demonstrated that feedback was beneficial only in the complex tasks (block turn, clothespin and cups relocation), and that the training had an important, task-dependent impact. In the clothespin relocation and block turn tasks, training allowed the subjects to establish successful feedforward control, and therefore, the feedback became redundant. In the cups relocation task, however, the subjects needed some training to learn how to properly exploit the feedback. The subjective evaluation of the feedback was consistently positive, regardless of the objective benefits. These results underline the multifaceted nature of closed-loop prosthesis control as, depending on the context, the same feedback interface can have different impact on performance. Finally, even if the closed

  14. Preanalytical quality in clinical chemistry laboratory.

    Science.gov (United States)

    Ahmad, M Imteyaz; Ramesh, K L; Kumar, Ravi

    2014-01-01

    Haemolysis is usually caused by inadequate specimen collection or preanalytical handling and is suggested to be a suitable indicator of preanalytical quality. We investigated the prevalence of detectable haemolysis in all routine venous blood samples in OPDs and IPDs to identify differences in preanalytical quality. Haemolysis index (HI) values were obtained from a Vitros 5,1 in the routine clinical chemistry laboratory for samples collected in the outpatient department (OPD) collection centres, a hospital, and inpatient departments (IPD). Haemolysis was defined as a HI > or = 15 (detection limit). Samples from the OPD with the highest prevalence of haemolysis were 6.1 times (95% confidence interval (CI) 4.0 - 9.2) more often haemolysed compared to the center with the lowest prevalence. Of the samples collected in primary health care, 10.4% were haemolysed compared to 31.1% in the IPDs (p = 0.001). A notable difference in haemolysed samples was found between the IPDs section staffed by emergency medicine physicians and the section staffed by primary health care physicians (34.8% vs. 11.3%, p = 0.001). The significant variation in haemolysis indices among the investigated units is likely to reflect varying preanalytical conditions. The HI is a valuable tool for estimation and follow-up of preanalytical quality in the health care laboratory.

  15. The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study.

    Science.gov (United States)

    Schutte, Tim; van Eekeren, Rike; Richir, Milan; van Staveren, Jojanneke; van Puijenbroek, Eugène; Tichelaar, Jelle; van Agtmael, Michiel

    2018-01-01

    In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. The quality of report documentation was assessed with the "Clinical Documentation tool to assess Individual Case Safety Reports" (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR. Nurses' opinions of the assignment were evaluated using an E-survey. Thirty-three ADRs were reported, 32 (97%) of which were well documented according to ClinDoc. Thirteen ADRs (39%) were "serious" according to CIOMS criteria. In five cases (15%), the suspect drugs were listed for additional monitoring by EMA and in seven cases (21%), the ADR was not mentioned in the Summary of Product Characteristics. Twenty-five (78.1%) of the 32 enrolled nurses completed the E-survey. Most were > 45 years of age (68%), female (92%) and had extensive clinical experience (6-33 years). All agreed or completely agreed that the reporting assignment was useful, that it fitted in daily practice and that it increased their attention for medication/patient safety. A large majority (84.0%) agreed the assignment changed how they dealt with ADRs. Specialist oncology nurses are capable of reporting ADRs, and they considered the assignment useful. The assignment yielded valuable, relevant, and well-documented ADR reports for pharmacovigilance practice.

  16. Clinic Workload, the Quality of Staff Relationships and Diabetes Management in Community Health Centers Catering to Latino and Chinese Patients.

    Science.gov (United States)

    Vargas Bustamante, Arturo; Martinez, Ana; Chen, Xiao; Rodriguez, Hector P

    2017-06-01

    We examine whether workplace climate-quality of staff relationships (QSR) and manageable clinic workload (MCW) are related to better patient care experiences and diabetes care in community health centers (CHCs) catering to Latino and Chinese patients. Patient experience surveys of adult patients with type 2 diabetes and workplace climate surveys of clinicians and staff from CHCs were included in an analytic sample. Comparisons of means analyses examine patient and provider characteristics. The associations of QSR, MCW and the diabetes care management were examined using regression analyses. Diabetes care process were more consistently provided in CHCs with high quality staff relations and more manageable clinic workload, but HbA1c, LDL cholesterol, and blood pressure outcomes were no different between clinics with high vs. low QSR and MCW. Focusing efforts on improvements in practice climate may lead to more consistent provision of important processes of diabetes care for these patients.

  17. Quality management systems for your in vitro fertilization clinic's laboratory: Why bother?

    Science.gov (United States)

    Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter

    2013-01-01

    Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.

  18. Precision Oncology Medicine: The Clinical Relevance of Patient-Specific Biomarkers Used to Optimize Cancer Treatment.

    Science.gov (United States)

    Schmidt, Keith T; Chau, Cindy H; Price, Douglas K; Figg, William D

    2016-12-01

    Precision medicine in oncology is the result of an increasing awareness of patient-specific clinical features coupled with the development of genomic-based diagnostics and targeted therapeutics. Companion diagnostics designed for specific drug-target pairs were the first to widely utilize clinically applicable tumor biomarkers (eg, HER2, EGFR), directing treatment for patients whose tumors exhibit a mutation susceptible to an FDA-approved targeted therapy (eg, trastuzumab, erlotinib). Clinically relevant germline mutations in drug-metabolizing enzymes and transporters (eg, TPMT, DPYD) have been shown to impact drug response, providing a rationale for individualized dosing to optimize treatment. The use of multigene expression-based assays to analyze an array of prognostic biomarkers has been shown to help direct treatment decisions, especially in breast cancer (eg, Oncotype DX). More recently, the use of next-generation sequencing to detect many potential "actionable" cancer molecular alterations is further shifting the 1 gene-1 drug paradigm toward a more comprehensive, multigene approach. Currently, many clinical trials (eg, NCI-MATCH, NCI-MPACT) are assessing novel diagnostic tools with a combination of different targeted therapeutics while also examining tumor biomarkers that were previously unexplored in a variety of cancer histologies. Results from ongoing trials such as the NCI-MATCH will help determine the clinical utility and future development of the precision-medicine approach. © 2016, The American College of Clinical Pharmacology.

  19. Clinical relevance of herpes simplex virus viremia in Intensive Care Unit patients.

    Science.gov (United States)

    Lepiller, Q; Sueur, C; Solis, M; Barth, H; Glady, L; Lefebvre, F; Fafi-Kremer, S; Schneider, F; Stoll-Keller, F

    2015-07-01

    To determine the clinical relevance of herpes simplex virus (HSV) viremia episodes in critically ill adult patients. 1556 blood samples obtained for HSV PCR analysis in Intensive Care Unit (ICU) patients over 4 years were retrospectively analyzed, focusing on the comprehensive analysis of 88 HSV-viremic patients. HSV DNA was detected in 11.8% of samples from the ICU. HSV viral loads remained below 5×10(2) copies/ml in 68.2% of patients and exceeded 10(4) copies/ml in 7.9%. Episodes of HSV-viremia correlated with immunosuppressed status and mechanical ventilation in 79.5% and 65.9% of patients, respectively. Only a subset of patients exhibited HSV-related organ damage, including pneumonia and hepatitis (10.2% and 2.3%, respectively). The mortality rate in HSV-viremic patients was not significantly increased compared to the overall mortality rate in the ICU (27.3% vs. 22.9%, p = 0.33). Only patients with high HSV viral loads tended to have a higher, though non-significant, death rate (57.1%, p = 0.14). Our results suggest HSV viremia is common in ICU patients, potentially favored by immunocompromised status and mechanical ventilation. The global impact of HSV-viremia on mortality in the ICU was low. Quantifying HSV DNA may help identifying patients at-risk of severe HSV-induced symptoms. Copyright © 2015 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

  20. Relevance of P-glycoprotein on CXCR4+ B cells to organ manifestation in highly active rheumatoid arthritis.

    Science.gov (United States)

    Tsujimura, Shizuyo; Adachi, Tomoko; Saito, Kazuyoshi; Kawabe, Akio; Tanaka, Yoshiya

    2018-03-01

    In rheumatoid arthritis (RA), P-glycoprotein (P-gp) expression on activated B cells is associated with active efflux of intracellular drugs, resulting in drug resistance. CXCR4 is associated with migration of B cells. This study was designed to elucidate the relevance of P-gp expression on CXCR4 + B cells to clinical manifestations in refractory RA. CD19 + B cells were analyzed using flow cytometry and immunohistochemistry. P-gp was highly expressed especially on CXCR4 + CD19 + B cells in RA. The proportion of P-gp-expressing CXCR4 + B cells correlated with disease activity, estimated by Simplified Disease Activity Index (SDAI), and showed marked expansion in RA patients with high SDAI and extra-articular involvement. In highly active RA, massive infiltration of P-gp + CXCR4 + CD19 + B cells was noted in CXCL12-expressing inflammatory lesions of RA synovitis and RA-associated interstitial pneumonitis. In RA patient with active extra-articular involvement, intracellular dexamethasone level (IDL) in lymphocytes diminished with expansion of P-gp + CXCR4 + CD19 + B cells. Adalimumab reduced P-gp + CXCR4 + CD19 + B cells, increased IDL in lymphocytes, and improved the clinical manifestation and allowed tapering of concomitant medications. Expansion of P-gp + CXCR4 + B cells seems to be associated with drug resistance, disease activity and progressive destructive arthritis with extra-articular involvement in RA.